Syringe packaging system for hospital pharmacies

ABSTRACT

A semi-automated system ( 100 ) suitable for use in a hospital setting for filling patient-specific liquid medication prescriptions from balk medicine containers ( 104 ) into oral syringes (S) for administration on a just-in-time basis. The system enables hospital pharmacists to simplify and streamline their task, increasing the number of prescriptions mat can be filled in a day, improving patient safety and care by minimizing medication errors and the consequences that ensue. The present invention also includes a novel adapter cap for use in interfacing between bulk medicine containers ( 104 ) and syringes (S) having a Luer-lock fitting.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application derives priority from U.S. provisional patentapplication Ser. No. 61/932,318, filed Jan. 28, 2014, which is acontinuation-in-part of U.S. patent application Ser. No. 13/236,577,filed Sep. 19, 2011 (which derives priority from U.S. provisional patentapplication Ser. No. 61/384,217 filed Sep. 17, 2010, and U.S.provisional patent application Ser. No. 61/494,677 filed Jun. 8, 2011),all of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to oral syringe packagingequipment and more specifically to a partially automated system forpreparing patient-specific doses of selected pharmaceutical liquidmedication for administration by oral syringe on a just-in-time basis,for use in a hospital pharmacy.

2. Description of the Background

Oral syringes are well known instruments in the medical fields and areused to administer liquid medicine into the mouth, as an alternative topills which can present a choking hazard or be expectorated, typicallyfor infants/children and uncooperative or geriatric adults. The oralsyringe directs liquid medicine to the back of the throat prompting aswallowing response. Injectable syringes, on the other hand, are used toadminister medication into the body by injecting its contents throughthe skin. Injectable syringes utilize a needle on the tip of thesyringe. Injectable syringes must be manufactured and packaged in asterile environment. Research has shown that the potential for adversedrug events within the pediatric inpatient population is about threetimes as high as among hospitalized adults. See, Joint Commission,Preventing Pediatric Medication Errors, Issue 39 (2008). According tothe Commission Report, the most common types of harmful pediatricmedication errors were improper dose/quantity (37.5 percent) andunauthorized/wrong drug (13.7 percent), followed by improper preparationor dosage form. Oral syringes help to minimize these problems and areconsidered the gold standard for delivering medicine to children.

Oral syringes, which are relatively inexpensive and disposable, arecomprised of a simple piston pump with a plunger that fits tightly inone end of a cylindrical tube (the barrel) and can be pushed or pulledalong inside the barrel to create negative or positive relative pressurewithin the barrel that causes the syringe to take in or expel a liquidor gas through an orifice (nozzle) at the opposing end of the barrel. Anannular flange partially or fully encircling the outside surface of thebarrel is typically provided to facilitate compression of the plungerinto the barrel. The barrel of an oral syringe is typically made ofplastic and is at least partially transparent along its length withgraduated markings to indicate the volume of fluid in the syringe basedon the position of the plunger, which is thus visible within the barrel.Oral syringes are commonly marked in units of milliliters and come instandard sizes ranging from 0.5 to 60 milliliters. The plunger is alsotypically plastic as this provides a good seal within the barrel and isinexpensive to produce so as to be disposable, reducing the risk ofcontamination or transmission of communicable disease. Oral syringescome in a wide range of sizes and with some variation in configuration.For example, some oral syringes have the nozzle located along thecentral axis while others have the nozzle offset from the central axis.This variability makes it difficult to automate the filling process fororal syringes.

Pharmacies at in-patient medical facilities and other medicalinstitutions fill a large number of prescriptions on a daily basisincluding prescriptions for liquid or compounded suspension medicines tobe administered by oral syringe, and must do so accurately for medicalsafety reasons. The volume of an oral pediatric prescription's dose isdetermined by the child's weight. This makes it impractical to stockpre-filled syringes due to the wide range of fill volumes required. As aresult, pediatric oral liquid doses are prepared in the hospitalpharmacy on a patient-specific, just-in-time basis. The process offilling numerous, variously sized single dose prescriptions for deliveryby oral syringe is time consuming, labor intensive and prone to humanerror. To ensure that the medication is packaged error-free, thepharmacy technician must make sure that: (1) the syringe contains thecorrect medication; (2) the syringe contains the correct amount ofmedication; (3) the syringe is capped correctly; (4) the medication hasnot expired; (5) the medication has not been recalled; (6) themedication, when required, is shaken; (7) the medication, when required,has been properly refrigerated; (8) the medication, when required, hasbeen properly protected from exposure to light; (9) the information onthe syringe label is correct; (10) the syringe is placed into thecorrect bag; (11) the information on the bag containing the syringe iscorrect; (12) the bag is properly sealed; and (13) the syringe isprotected from cross contamination from other medications. The processtypically requires a pharmacist or pharmacy technician to retrieve thecorrect medication from a storage cabinet (with or without lightprotection) or refrigerated storage area. The liquid medications aretypically stored in a container sealed with a safety cap or seal. Afterconfirming the contents of the retrieved container and shaking themedication (if necessary), the technician manually opens the cap andinserts the tip of an oral syringe into the container which haspreviously been adapted to accept the syringe, inverts the container,and then withdraws the plunger to draw the medication into the barrel ofthe syringe. After filling with a proper amount, the syringe andmedication container are rotated back to the original position, thesyringe is removed from the container, the tip of the syringe is coveredwith a cap for transport to the patient and the syringe is labeled toindicate its content and the intended recipient, and then bagged. Priorto administering the dose, the nurse can determine the amount of thedose by observing where the tip of the plunger or piston is located inthe barrel.

Currently, the degree of automation in the hospital pharmacy for thepackaging of oral syringes is very limited. Islands of automation exist,such as automatic labeling of the syringe and bagging of the filled andcapped syringe to indicate to the administering nurse the content of thesyringe. However, the filling and capping of oral syringes are donemanually. Scanners, cameras, bar code readers and track-and-tracetechnology have not been applied on an integrated, comprehensive basisfor the packaging of oral syringes in the hospital pharmacy. Thepotential to reduce medication errors using this technology is thussignificant. Automated systems have been developed by Baxa, Inc., ForHealth Technologies, Inc., Intelligent Hospital Systems and others forthe automated filling of injectable syringes.

For example, U.S. Pat. Nos. 6,991,002; 7,017,622; 7,631,475 and6,976,349 are all drawn to the automated removal of a tip cap from anempty syringe, the placement of the tip cap at a remote location, andthe replacement of the tip cap on a filled syringe. U.S. Pat. Nos.7,117,902 and 7,240,699 are drawn to automated transfer of a drug vialfrom storage to a fill station. U.S. Pat. No. 5,884,457 shows a methodand apparatus for filling syringes using a pump connected by a hose to afluid source. U.S. Pat. No. 7,610,115 and Application Publication2010/0017031 show an Automated Pharmacy Admixture System (APAS). U.S.Application Publication 2009/0067973 shows a gripper device for handlingsyringes of different diameters with tapered or angled gripper fingers.U.S. Pat. No. 7,343,943 shows a medication dose under-fill detectionsystem. U.S. Pat. No. 7,260,447 shows an automated system for fulfillingpharmaceutical prescriptions. U.S. Pat. No. 7,681,606 shows an automatedsystem and process for filling syringes of multiple sizes. U.S. Pat. No.6,877,530 shows an automated means for withdrawing a syringe plunger.U.S. Pat. No. 5,692,640 shows a system for establishing and maintainingthe identity of medication in a vial using preprinted, pressuresensitive, syringe labels.

The foregoing reference machines for packaging injectable syringes. Thepackaging process required for injectable syringes is significantlydifferent than that for oral syringes. Injectable syringes must bepackaged in a sterile environment, as the medication is injected intothe body. This requirement adds cost and complexity to the machine.Injectable medications, when packaged on a just-in-time basis as withthe Baxa, For Health Technologies, and Intelligent Hospital Systemmachines, must typically be prepared by the machine before themedication is filled into the syringe. The medication preparationprocess involves diluting the medication or reconstituting themedication from a powdered state with water. This process adds expenseand slows down the packaging process as well. The Intelligent HospitalSystems syringe packaging system is designed to be used to packagecytotoxic medications which are hazardous. To avoid harm to theoperator, this machine uses a robot located within an isolating barrierat considerable cost. The Baxa, For Health Technologies, and IntelligentHospital System machines require the use of expensive disposable productcontact parts when a different medication is to be filled. The foregoingmachines are not suitable for packaging oral syringes due to theircapital cost, complexity, slow production rates, inability to handleoral medication containers, the requirement of expensive disposablecontact parts, and other features that add unnecessary cost andcomplexity to the process for filling and packaging oral syringes.Consequently, existing automation does not address the needs of medicalinstitutions desiring an affordable pharmacy automation system forpatient safety, prescription tracking and improved productivity in thefilling and packaging of oral syringes. The present invention wasdeveloped to fill this void.

Oral syringes are manufactured in a variety of sizes with differing tipand plunger configurations, as described in part above. Moreover, oralmedications are commonly provided and/or stored in bulk form invariously sized, manufacturer-supplied (OEM) bottles or containershaving threaded screw caps that must be removed and replaced betweenuses. Under the prior art, in order to fill an oral syringe from themanufacturer-supplied container, the original container cap must bereplaced with a cap that allows insertion of an oral syringe nozzle.Baxa™ sells an “Adapta-Cap”™ bottle adapter in a variety of sizes thatreplaces the OEM caps to convert a standard prescription or manufacturerbottle into a filling device for oral syringes. These Adapta-Cap™ bottleadapters are screw-on caps with open center-holes capable of acceptingan oral syringe nozzle, and a tethered closure. This enables an oralsyringe to enter its center hole and withdraw an amount of liquid fromthe medication container while the medication container is positionedupside down. Unfortunately, the Adapta-Cap™ bottle adapters have nointernal valves and are not self-sealing. Thus, for the syringe to beremoved from the medication container, both syringe and medicationbottle must be up-righted. Once up-righted, the syringe can be removedfrom the up-righted medication bottle with no leakage. If the medicationbottle requires shaking at any given time, it must be done manually orin a separate shaker while upright when using the prior art Adapta-Cap™.

It is known that an adapter cap can include a self-sealing valve forthis purpose. For example, U.S. Pat. No. 8,459,312 to Manera et al.(Comar) issued Jun. 11, 2013 shows an adapter to be pressed into theneck of a bottle to receive a syringe for accessing the bottle contentsby a syringe. The adapter has a normally closed valve located at thatdistal end to prevent the contents from leaking out of the bottle if thebottle is inverted. A very similar construct was shown in United StatesPatent Application 20110130740 by Levy (Baxa) published Jun. 2, 2011(now abandoned). U.S. Pat. No. 4,493,348 shows a method and apparatus inwhich oral syringes can be filled using a screw-on adapter cap 12 forconnecting the bulk medicine container 10 and a syringe 14 so that theliquid medication can be transferred from the bulk container 10 into thesyringe barrel 20. The syringe is inserted into a nozzle 88 of theadapter cap 12 and displaces a detent valve 92 (see U.S. Pat. No.4,493,348 FIG. 6) that allows medicine to flow through the nozzle 88into the syringe. When not in use the nozzle 88 may be closed off by aplug 50 attached to a tether 48. The adapter cap 12 is well-suited formanual filling of oral syringes but is not suitable for automatedfilling.

Additionally, all of the foregoing adapters allow a tapered tip oralsyringe to enter a center hole and withdraw an amount of liquid from themedication container while the medication container is positioned upsidedown, allow an oral syringe be removed from the container while thecontainer is inverted, without leaking, and allow the medicationcontainer to be shaken while it is positioned upside down withoutleaking. However, none can accommodate an oral syringe with a Luer-locktip. The Luer-lock tip syringe, includes a circular hub about the oralsyringe nozzle that screws into in a threaded sleeve on the medicinecontainer cap (see FIG. 39). As a result of a worldwide InternationalStandards Organization directive ISO-80369, certain syringe types willbe required to employ Luer-lock fittings to reduce the risk ofmisconnections between tubes, IV's, enteral devices, etc. In order toaccommodate this change, any syringe fill automation system orsemi-automatic system suitable for use in a hospital setting should beable to interface syringes with a Luer-lock fitting to a medicinecontainer equipped with an adapter cap that preferably allows insertion,filling and withdrawal in any orientation without leaking, and whichpreferably enables the medication container to be shaken withoutleaking. Thus, preferably, a system of filling oral syringes shouldinterface both Luer-lock and tapered tip oral syringes with medicinecontainers equipped with the appropriate adapter cap. A self-sealingadapter cap may accomplish these goals.

Given the diversity of oral syringes and medicine containers available(and in use), any semi-automated (or fully-automated) system will needsufficient dexterity to manipulate all the myriad prescription bottlescontaining the pharmaceuticals to be dispensed as well as variouslysized oral syringes with tapered and Luer-lock tips, bringing themtogether in a controlled environment to quickly and accurately fill andlabel each syringe and to verify its work as it proceeds in order toavoid errors in the process. Such a system would need to be reliablyconstructed so as to minimize downtime, quickly take and fill orders, beeasy to clean and capable of maintaining an environment free from crosscontamination. Such a system would also need to be able to interact witha human operator at multiple points in the operation.

Additionally, in-patient medical facilities such as hospitals are movingtoward electronic prescription (“e-prescription”) systems which usecomputer systems to create, modify, review, and/or transmit medicationprescriptions from the healthcare provider to the pharmacy. Whilee-prescribing improves patient safety and saves money by eliminating theinefficiencies and inaccuracies of the manual, handwritten prescriptionprocess, any syringe fill automation system suitable for use in ahospital setting must interface with an existing e-prescription system(which records and transmits prescriptions to the pharmacy), and must becapable of filling prescription orders in a just-in-time environment.

SUMMARY OF THE INVENTION

The present inventors herein provide a semi-automated system suitablefor use in a hospital setting for filling patient-specific doses ofliquid medications to be administered by oral syringes on a just-in-timebasis. The system enables hospital pharmacists to simplify andstreamline their task, increasing the number of prescriptions that canbe filled in a day, and improving patient safety and care by minimizingmedication errors and the consequences that ensue.

The present invention also provides fourteen embodiments of a medicationcontainer adapter for oral syringe filling system. The preferredembodiment is a self-sealing valve which allows the container to remainin an inverted position for the entire time the syringes are beingfilled. In addition the container may be shaken without removal from theshake station.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects, features, and advantages of the present invention willbecome apparent from the following detailed description of the preferredembodiments and certain modifications thereof when taken together withthe accompanying drawings in which like numbers represent like itemsthroughout and in which:

FIG. 1 is a flow chart of the overall method of the invention.

FIG. 2 is a perspective view of the entire pharmacy automation system100 according to an embodiment of the invention.

FIG. 3 is a more detailed flowchart of the substeps of the batchfulfillment process 750 of FIG. 1.

FIG. 4 is a more detailed block diagram of the medication containerorientation and log-in process 720 of FIG. 1.

FIG. 5 is a composite view of six of the embodiments ofcontainer/syringe interfaces according to the invention. Thecontainer/syringe interfaces include closures and neck inserts meant tofacilitate the connection of an oral syringe to a medication containerfor the purpose of drawing fluid out of the container.

FIGS. 6A and 68B are perspective views of an exemplary vision inspectionstation 9.

FIG. 6C shows an alternative articulating design for the backlight panel97.

FIG. 6D shows another alternative articulating design for the backlightpanel 97.

FIG. 7A is an enlarged perspective view of a semi-automated syringe fillstation 5 for filling the syringes S.

FIG. 7B is a composite view of a self-centering spring loaded bottlegripper assembly 82C used as an alternative to fixed yokes 82 of FIG.7A.

FIG. 7C I is an enlarged perspective view of fixed yoke 82A illustratinghow it is used.

FIG. 7C II is an enlarged perspective view of fixed yoke 82Billustrating how it is used.

FIG. 7C III is an enlarged perspective view of self-centering jaws 82Cillustrating how they is used.

FIG. 7C IV is an enlarged perspective view of fixed yoke 82Dillustrating how it is used.

FIG. 7D is a further enlarged perspective view of the loading carriage70 of FIG. 7A.

FIG. 8 is a composite view of the syringe gripping arms 110, 111 and 112terminating in a pair of fork shaped fingers 120 that form ahorizontally oriented “V” shaped opening.

FIG. 9 illustrates an embodiment of the syringe gripping arms 111 andits drive mechanism.

FIG. 10 is an enlarged perspective view of the semi-automated cappingstation 8.

FIGS. 11 and 12 illustrate an exemplary control system architecture forthe system 100 of FIGS. 2-10.

FIG. 13 is a perspective view of an exemplary capping/decapping station93 resident at the Medication Container Orientation and Log-In Station.

FIG. 14 is a perspective view of the optional label photographingstation 98 resident at the Medication Container Orientation and Log-InStation.

FIG. 15A is a perspective view of an embodiment of the syringesize/color station 11A which verifies that the correct syringe has beenselected.

FIG. 15B is a perspective view of an alternate embodiment of the syringesize/color station 11B which verifies that the correct syringe has beenselected.

FIG. 16A illustrates an embodiment of a shaking mechanism 820 integralto the filling station 5.

FIG. 16B is a composite operational diagram illustrating the operationof the integral shaking mechanism 820 of FIG. 16A.

FIG. 17 is a perspective view of an alternative, remote medicationcontainer shake station 6.

FIG. 18 is a sequential illustration of the process for filling asyringe S using a standard commercially available “Baxa” cap 214;

FIG. 19 is a sequential illustration of the process for filling asyringe S using an OEM-Baxa™ Cap with self sealing valve 216.

FIG. 20 is a sequential illustration of the process for filling asyringe S using a press in bottle adapter (PIBA) (no valve) 210;

FIG. 21 is a sequential illustration of the process for filling asyringe S using a PIBA (with valve) 212.

FIG. 22A is a process drawing depicting grouped stations with a multiplesyringe compartment tray (Option 3);

FIG. 22B is a process drawing with one operator and three and groupedstations (Option 2);

FIG. 23 is a process drawing with three operators and three and threegrouped stations (Option 3).

FIG. 24 is a process drawing with two operators situated around a lazySusan (carousel-like) disc 342.

FIG. 25 is a process drawing with three (3) operators situated around alazy Susan (carousel-like) disc 342.

FIG. 26 illustrates an embodiment of a syringe gripping module havingcurvilinear distal ends.

FIG. 27 is a composite view (A, B and C) of a press in tip 223 for aBaxa™ or Baxa™-equivalent manufacturer-supplied medication container capto interface with a Luer lock oral syringe.

FIG. 28 is a composite view (A, B and C) of a press in tip 223 for aPIBA to interface with a Luer lock oral syringe.

FIG. 29 is composite view (A, B and C) of a push-pull cap 224 for aBaxa™ or Baxa™-equivalent manufacturer-supplied medication container capto interface with a Luer lock oral syringe.

FIG. 30 is composite view (A, B and C) of a push-pull cap 224 madeintegral with a Baxa™ or Baxa™-equivalent manufacturer-suppliedmedication container cap to interface with a Luer lock oral syringe.

FIG. 31 is composite view (A, B, C and D) of a push-pull cap 224 for aPIBA cap to interface with a Luer lock oral syringe.

FIG. 32 is composite view (A, B and C) made integral with a push-pullcap 224 for a PIBA cap to interface with a Luer lock oral syringe.

FIG. 33 is a composite view (A and B) of a self-sealing press in bottleadapter (SSPIBA) for use with a tapered tip syringe.

FIG. 34 is a composite view (A and B) of a threaded cap modified with aduckbill valve having automation grooves for use with a tapered tipsyringe.

FIG. 35 is FIG. 29 is composite view (A and B) of a Baxa™ orBaxa™-equivalent manufacturer-supplied medication container cap modifiedwith a duckbill valve to interface with a tapered tip oral syringe.

FIG. 36A illustrates a tethered protective cap for push-pull cap 224 foruse in semi-automatic operations.

FIG. 36B illustrates a separate protective cap for push-pull cap 224 foruse in fully automated operations.

FIG. 37A illustrates a tethered protective cap for modified Baxa™ orBaxa™-equivalent manufacturer-supplied medication container cap withduckbill valve for use in semi-automatic operations.

FIG. 37B illustrates a separate protective cap for modified Baxa™ orBaxa™-equivalent manufacturer-supplied medication container cap withduckbill valve for use in fully automated operations.

FIG. 38 is a side view of a tapered tip oral syringe.

FIG. 39 is a side view of a Luer lock oral syringe.

FIG. 40 is a perspective view of filling station 5 according to anotherembodiment of the present invention comprising a grooved block 400 foractuating push-pull adapter cap 224.

FIG. 41 is an enlarged perspective view of the actuation mechanism forfilling station 5 according to the embodiment shown in FIG. 40.

FIG. 42 is an enlarged perspective view of the actuation mechanism forfilling station 5 comprising a grooved block 400 for actuating push-pulladapter cap 224 according to another embodiment of the present invention

FIG. 43 is a composite view (A and B) of the interaction betweenpush-pull cap 224, grooved block 400 and yoke 82 according to theembodiments illustrated in FIGS. 40-42.

FIG. 44 is a composite view (A, B and C) of a valveless PIBA 210retrofit to include an integral valve 225 (typically, a duckbill valve)for use with a tapered tip syringe.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the exemplary embodimentillustrated in the drawings and described below. The embodimentdisclosed is not intended to be exhaustive or limit the invention to theprecise form disclosed in the following detailed description. Rather,the embodiment is chosen and described so that others skilled in the artmay utilize its teachings. It will be understood that no limitation ofthe scope of the invention is thereby intended. The invention includesany alterations and modifications in the illustrated device, the methodsof operation, and further applications of the principles of theinvention which would normally occur to one skilled in the art to whichthe invention relates.

The present invention includes both the system hardware as well as theprocess for preparing and tracking prescriptions of oral syringes by aseries of integrated manual and automated steps with respect topreparing the syringe and the bulk medicine, and subsequently bringingthe series together for filling the former from the latter. The bulkmedicine is typically supplied in manufacturer-supplied medicinecontainers with conventional screw-on caps. To facilitate processing thepresent system also envisions the use of one or more specialized adaptercaps for interfacing with tapered or Luer lock type oral syringes;alternatively, another type of specialized cap may be provided tospecification, or the OEM cap may be replaced or retrofitted with anyavailable type of container/syringe interface to provide a penetrableorifice. As described more fully below, the retrofit may be accomplishedin a number of ways. One solution is a press in bottle adapter (PIBA),e.g., a press-in plug inserted into the neck opening of a medicationcontainer which enables an oral syringe to enter its center hole andwithdraw an amount of liquid from the medication container while themedication container is positioned up-side-down. Another is a modifiedmanufacturer-supplied cap. Another is an adapter cap specially designedto modify a manufacturer-supplied cap to interface with a Luer lock oralsyringe. Specifically, the present invention contemplates fourteen (14)container/syringe interface variations: (1) a valve-less press in bottleadapter (PIBA) 210 (FIG. 5); (2) a self sealing PIBA (SSPIBA) 212 withan integral valve (typically, either a linear or a Z-shaped slit) 213(FIG. 5); (3) a standard manufacturer-supplied (Baxa™ or Baxaequivalent) valve-less medicine container cap 214 with opening (FIG. 5);(4) a modified manufacturer-supplied (Baxa™ or Baxa equivalent) medicinecontainer cap 216 that is retrofit to include an integral valve 225(typically, a duckbill valve) (FIG. 5); (5) a two-piece cap comprisingan outer portion 220 with a common outer diameter for all standard sizesof medication container, and a self-sealing insert 212 (FIG. 5); (6) acap 221 comprising a common outer diameter for all standard sizes ofmedication container and having an integral self-sealing insert 212(FIG. 5); (7) a modified manufacturer-supplied (Baxa™ or Baxaequivalent) medicine container cap 214 that is retrofit to include anon-integral push-in tip 223 for interfacing with Luer lock oralsyringes (FIG. 27); (8) a modified PIBA 210 that is retrofit to includea non-integral push-in tip 223 for interfacing with Luer lock oralsyringes (FIG. 28); (9) a modified manufacturer-supplied (Baxa™ or Baxaequivalent) medicine container cap 214 that is fitted with a push-pullcap 224 for interfacing with Luer lock oral syringes (FIG. 29); (10) amodified manufacturer-supplied (Baxa™ or Baxa equivalent) medicinecontainer cap 214 that is retrofit with an integral push-pull cap 224for interfacing with Luer lock oral syringes (FIG. 30); (11) a modifiedPIBA 210 that is fitted with a push-pull cap 224 for interfacing withLuer lock oral syringes (FIG. 31); (12) a modified PIBA 210 that isretrofit with an integral push-pull cap 224 for interfacing with Luerlock oral syringes (FIG. 32); (13) a cap 226 comprising a common innerdiameter for all standard sizes of medication container, fitted with anintegral or separable valve 225 (typically, a duckbill valve), andhaving grooved rings to facilitate handling, positioning, etc. by thesystem according to the present invention (FIG. 34); and/or (14) avalveless PIBA 210 that is retrofit to include an integral valve 225(typically, a duckbill valve) (FIG. 44). The chart below summarizes thefourteen (14) adapter cap variations according to the current invention:

No. Description of adapter interface FIG. No. Reference No. 1 valve-lesspress in bottle adapter (PIBA) 5 210 2 self sealing PIBA (SSPIBA) withan integral valve 5 212/213 (typically, either a linear or a Z-shapedslit) 3 standard manufacturer-supplied (Baxa ™ or Baxa 5 214 equivalent)valve-less medicine container cap with opening 4 modifiedmanufacturer-supplied (Baxa ™ or Baxa 5 216/225 equivalent) medicinecontainer cap that is retrofit to include an integral valve (typically,a duckbill valve) 5 two-piece cap comprising an outer portion with a 5220/212 common outer diameter for all standard sizes of medicationcontainer, and a self-sealing insert 6 cap comprising a common outerdiameter for all 5 221/212 standard sizes of medication container andhaving an integral self-sealing insert 7 modified manufacturer-supplied(Baxa ™ or Baxa 27 214/223 equivalent) medicine container cap that isretrofit to include a non-integral push-in tip for interfacing with Luerlock oral syringes 8 modified PIBA that is retrofit to include a non- 28210/223 integral push-in tip for interfacing with Luer lock oralsyringes 9 modified manufacturer-supplied (Baxa ™ or Baxa 29 214/224equivalent) medicine container cap that is fitted with a push-pull capfor interfacing with Luer lock oral syringes 10 modifiedmanufacturer-supplied (Baxa ™ or Baxa 30 214/224 equivalent) medicinecontainer cap that is retrofit with an integral push-pull cap forinterfacing with Luer lock oral syringes 11 modified PIBA that is fittedwith a push-pull cap for 31 210/224 interfacing with Luer lock oralsyringes 12 modified PIBA that is retrofit with an integral push- 32210/224 pull cap for interfacing with Luer lock oral syringes 13 capcomprising a common inner diameter for all 34 225/226 standard sizes ofmedication container, fitted with an integral or separable valve(typically, a duckbill valve), and having grooved rings to facilitatehandling, positioning, etc. by the system according to the presentinvention 14 valveless PIBA that is retrofit to include an integral 44210/225 valve (typically, a duckbill valve)

FIG. 5 is a composite view of the first six of the embodiments of thecontainer/syringe interfaces according to the invention. The embodimentsshown in FIG. 5 are suited for use with a tapered tip syringe S as shownin FIG. 38. The tapered syringe includes an annular, tapered orcylindrical nozzle through which liquid medication must pass to enter orexit the body of the syringe. The nozzle contains an open centralchannel.

As shown in FIG. 5, two valveless embodiments include the PIBA 210 andOEM/Baxa Cap 214 at left, and four valved embodiments include the valvedPIBA 212, the valved self-sealing PIBA 212 integrally formed into, orcombinable with, the common diameter outer portion 220 or 221, and amodified/self-sealing OEM/Baxa Cap 216. All may be adapted to fit avariety of medicine bottle types and sizes.

The valved PIBA 212, OEM/Baxa Cap 216 and common outer diameter caps220, 221 all include a self-sealing valve that closes when the syringenozzle is removed to prevent leakage when the medication container is inthe inverted position at the fill station.

Both PIBAs 210, 212 comprise a press-fitted open plug inserted into theneck opening of a medication container. This enables an oral syringe toenter its center hole and withdraw an amount of liquid from themedication container while the container is positioned up-side-down.This syringe filling procedure must be repeated for each syringe to befilled. If the medication container with open PIBA 210 requires shakingthis must be done manually with the original screw cap replaced over theneck. The above procedure must be repeated every time shaking isrequired regardless of whether the same medication is being filled intomultiple syringes. Also, the original cap must be placed over theMedication bottle and its press-in insert, during storage, to ensurecleanliness.

OEM/Baxa Caps 214 (see FIG. 5) are the commercially available “Baxa”screw on adapter caps which are applied to the necks of medicationbottles to enable them to fill oral syringes. The standard commerciallyavailable “Baxa” cap consists of a female threaded cap to fit overmedication bottles and is available in sizes to accommodate mostmedication containers. It enables an oral syringe to enter its centerhole and withdraw an amount of liquid from the medication containerwhile the medication container is positioned upside down. For thesyringe to be removed from the medication container, both syringe andmedication bottle must be up-righted. Once up-righted, the syringe canbe removed from the up-righted medication bottle with no leakage. If themedication bottle requires shaking at any given time, it can be donemanually or in a separate shaker by closing the tethered cap andfastening the bottle into the shaking mechanism (see FIG. 17 below).

The valved OEM/Baxa Cap 216 (see FIG. 5) is preferablymodified/constructed with an elastomeric check valve member 225 heldcaptive in the plastic cap body 219. Examples of self-sealing valvesinclude check valves and simple diaphragms with a linear or a Z-shapedslit. Again, it is important to remember that valved interfaces 212, 216can be left inverted at the filling station 5 (FIG. 2 III 5) and evenshaken without leaking, whereas valveless interfaces 210, 214 (see FIG.5) do not prevent leakage. Thus, valveless interfaces 210, 214 compelremoval of the syringe/container combination from the filling station 5after each filling operation.

The elastomeric seal 225 (see FIG. 5) of the valved OEM/Baxa Cap 216 isfitted within an aperture in the flange of cap 219. In its simplest formthe elastomeric seal 225 may be a resilient, penetrable membrane with asmall hole or slot (such as a pinhole) punched at its center, andpreferably formed of silicone or other rubber. The hole in the seal 225expands as the tip of a syringe S is inserted to permit pressurizationof the container 104 (see FIG. 19) and/or filling of the syringe (byvacuum) as described below. On withdrawal of the syringe tip theresilient elastomeric seal 225 returns to its original shape closing thehole and preventing leakage of the fluid contents of the bottle 104.

FIG. 5 also shows cross-sections of alternative container/syringeinterfaces 210, 212 which comprise a PIBA fitted as a plug-in insertinto the neck of the medicine container. The PIBA is an annular bodysized to conform to the inside of the medicine container neck andadapted for a friction fit therein, and may be formed with ribs asdescribed above for this purpose. The interface 212 defines a centralconduit, and the elastomeric seal 213 is fitted within interface 212across this conduit to serve as a penetrable seal as described above.

As still another option, any conventional cap, such as Baxa's AdaptaCap™bottle adapter cap may be used (as shown in U.S. Pat. No. 4,493,348referenced above) and simply modified or equipped by the manufacturer oraftermarket with a penetrable elastomeric seal such as check valve 225,or other suitable self-sealing valve. In yet another embodiment of thepresent invention, a container/syringe interface includes an outerportion 220, 221 that will have the same outer circumference for use onany of the standard sizes of medication containers. It can be used witha purchased, self-sealing insert, such as valved PIBA 212, or the insertcan be integrally formed within the outer portion 221. The interfacebetween the medication container and the self-sealing insert will holdthe outer portion 220, 221 securely onto the top of the medicationcontainer, locating the outer part on center with the opening of themedication container. The cap with outer portion 220, 221 may alsoinclude a tethered protective cap (to protect the contents of themedication container from contamination, such as, for example, from dustor other airborne particles) similar to the Baxa type cap, as shown inFIG. 5. In one preferred embodiment, the 2D bar code, described infurther detail below, is affixed to the top of the tethered cap. Thecommon outer diameter of outer portion 220, 221 for all standard sizesof medication container caps can serve as a common means of locating themedication container on center with the yoke at the fill station. Thecommon size of the flange 222 of the outer portion 220, 221 of theinstant cap embodiment may also facilitate transportation of themedication containers when used with a carousel designed to hold asingle diameter syringe/container interface.

FIG. 44 shows a composite view of another valved embodiment of thecontainer/syringe interface for use with a tapered tip syringe:valveless PIBA 210 with integral or non-integral duckbill valve 225.This embodiment also may be adapted to fit a variety of medicine bottletypes and sizes. The valveless PIBA 210 with duckbill valve 225comprises a press-fitted open plug inserted into the neck opening of amedication container. An elastomeric check valve member 225 is theninserted into the center hole of PIBA 210. Examples of self-sealingvalves include check valves and simple diaphragms with a linear or aZ-shaped slit. The hole in the seal 225 expands as the tip of a syringeS is inserted to permit pressurization of the container 104 (see FIG.19) and/or filling of the syringe (by vacuum) as described below. Onwithdrawal of the syringe tip the resilient elastomeric seal 225 returnsto its original shape closing the hole and preventing leakage of thefluid contents of the bottle 104. The presently described valvedinterface 210/225 can be left inverted at the filling station 5 (FIG. 2III 5) and even shaken without leaking. However, the original cap mustbe placed over the Medication bottle and its press-in insert, duringstorage, to ensure cleanliness.

Additional preferred embodiments are illustrated with reference to FIGS.27-37 and 39. FIG. 39 depicts a Small Bore Luer Lock (also referred toherein as a “Luer-lock” syringe) syringe which has an inlet/outletopening flush with the top edge of the syringe body and bordered by anannular flange which creates a female connection point for a male nozzleto fill the syringe body with liquid medication through the inlet/outletpoint. FIG. 27 is a composite view (A, B & C) of a modifiedmanufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap214 that is retrofit to include a non-integral push-in tip 223 forinterfacing with Luer lock oral syringes, shown in cross-section.Push-in tip 223 is preferably composed of an annular body having atapered distal flange 223A, flange 223A having a diameter that decreasestowards the distal end of tip 223 for insertion into the nozzle of themanufacturer-supplied medication container cap 214. Tip 223 furthercomprises an annular flange 223B (having a diameter slightly larger thanthe diameter of the nozzle opening for cap 214) at its midpoint toprevent tip 223 from sliding all the way into cap 214. The end of tip223 opposite tapered flange 223A is sized to fit snugly within the outerflange of Luer Lock Syringe S, as shown in FIG. 27C. This designrequires the medication bottle to be upright while the syringe isinserted into the medication bottle nozzle. Then, both medication bottleand attached syringe are inverted as a unit and placed into the filler,as will be described. When syringe S is filled, both medication bottleand syringe are uprighted and the filled syringe is removed from themedication bottle. Tip 223 may use a separate cap 223C to preventspillage of the contents of the medication bottle when syringe S is notattached to tip 223.

FIG. 28 is a composite view (A, B & C) of a modified PIBA 210 that isretrofit to include a non-integral push-in tip 223 for interfacing withLuer lock oral syringes. As in FIG. 27, tip 223 comprises a tapereddistal flange 223A, flange 223A having a diameter that decreases towardsthe distal end of tip 223 for insertion into the nozzle of the PIBA cap210, while the opposite end of tip 223 is sized to fit snugly within theouter flange of Luer Lock Syringe S, as shown in FIG. 28C. Tip 223 mayuse a separate cap 223C to prevent spillage of the contents of themedication bottle when syringe S is not attached to tip 223.

FIG. 29 is a composite view (A, B & C) of a modifiedmanufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap214 that is fitted with a push-pull cap 224 for interfacing with Luerlock oral syringes. Cap 224 comprises two separately formed nozzlesections that are slidably connected in a male-female link. A stationaryportion 224A for attachment to a medication bottle comprises an annularbody with a central passage 80 therethrough, the central passage 80being defined by an inner wall having a specific progression ofdiametric variations. At one end of the body of stationary portion 224A,where stationary portion 224A attaches to the top of amanufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap214, central passage 80 has a relatively large diameter sized to conformto and receive the conventional Baxa™ oral medication cap with syringeaperture 214 as shown in FIG. 5. It will be understood by one ofordinary skill in the art, however, that stationary portion 224A may besized to fit a Baxa™-equivalent manufacturer-supplied cap based ondesign preference. Central passage 80 continues through stationaryportion 224A at a diameter sized to accommodate the upper,smaller-diameter nozzle portion of the conventional Baxa™ oralmedication cap 214, wherein the two diameters of central passage 80connect to define a shoulder 83 for press-fit anchoring of theconventional Baxa™ (or Baxa™-equivalent) oral medication cap 214. At amidpoint of the smaller diameter portion of central passage 80, atapered elastomer poppet 84, as will be described further herein, isanchored. The outer wall of stationary portion 224A may further compriseannular grooves for alignment with the yoke of the filling station, asfurther described herein.

At the distal end of stationary portion 224A opposite its attachmentwith the manufacturer-supplied medication container cap 214, stationaryportion 224A is slidably attached to a second, sliding portion 224B ofpush-pull cap 224. Sliding portion 224B also comprises a generallyannular body with a central passage 85 therethrough, the central passage85 being defined by an inner wall having a specific progression ofdiametric variations. At a first end, proximate the connection pointbetween stationary 224A and sliding 224B portions of cap 224, channel 85has a diameter sized to fit securely around the outer diameter of thedistal end of stationary portion 224A. Channel 85 continues throughsliding portion 224B to a shoulder 89 at the base of cap receivingchamber 60. Past shoulder 89, channel 85 progressively narrows indiameter, terminating in a nozzle 90 at the distal end of slidingportion 224B. Nozzle 90 is sized to fit securely around the tip ofpoppet 84 when cap 224 is closed to provide a secure, water tight fitbetween nozzle 90 and poppet 84. This configuration prevents any fluidmedications from leaking from the medication bottle when inverted uponremoval of the syringe from nozzle 90.

Cap 224 comprises a tab and groove locking mechanism to ensure positivelocking between stationary 224A and sliding 224B portions of cap 224 inboth open (FIG. 29 at A) and closed (FIG. 29 at B) positions. Thelocking mechanism comprises an annular tab 86 extending from the innerwall of channel 85 and flush with the distal end of sliding portion224B. Tab 86 corresponds in height and width to two grooves 87 a, 87 bin the outer wall of stationary portion 224A. When cap 224 is open, asshown in FIG. 29 (at A), tab 86 fits securely into groove 87 b, which islocated proximate the distal end of stationary portion 224A, creating achamber 60 within channel 85 to allow liquid medication to flow frommanufacturer-supplied medication container cap 214 through channel 80and around poppet 84 into channel 85 and out through nozzle 90 into theoral syringe during filling. Poppet 84 is anchored within stationaryportion 224A using one or more anchor points (see FIG. 29 at C, showingcross-section A-A through stationary portion 224A) that allow liquid toflow past poppet 84 as indicated by the dotted line in FIG. 29 (at A).Grooves 87 a, 87 b are spaced such that, when sliding portion 224B ispushed towards stationary portion 224A, tab 86 settles in groove 87 awhen the tip of poppet 84 is flush with the distal end of slidingportion 224B forming a water tight seal with nozzle 90. The exteriorwall of sliding portion 224B comprises an annular slide disc 91 to allowforce to be applied along the main axis of sliding portion 224B to openand close cap 224. At the distal end of sliding portion 224B proximateits connection with syringe S, the outer diameter of sliding portion224B is sized to fit inside the female nozzle of a Luer lock oralsyringe.

This design enables opening and closing the flow of medication to theLuer lock oral syringe while the medication container is inverted. Assuch, the time to load and unload, or upright and invert, the medicationcontainer between syringe fillings is eliminated. In addition, themedication container can also be shaken in an inverted position before,during or after a syringe filling operation, when the medication sorequires, as will be described. The design also allows for placement ofthe medication container bearing cap 224 into the Syringe Filler (to bedescribed) via a yoke in an automated or semi-automated process, and forslide disc 91, which controls the opening and closing of cap 224, to beautomated for use in a fully or semi-automated process. Push-pull capmay further comprise a 2D barcode, as further describe herein, on abottom edge of the slide disc 91 (facing up when medication container isinverted for filling operations) or elsewhere on cap 224 to enable easytracking of the medication container bearing that cap. Alternately, the2D barcode described herein may be placed on the base of the medicationcontainer.

FIG. 30 illustrates the push and pull-cap 224 of FIG. 29 wherein thedistal end of stationary portion 224A is made integral with medicationcontainer cap 214 by co-molding or like means known in the art. In thisembodiment, the threaded portion of cap 214 may be provided in severalstandard sizes, such as 20 mm, 24 mm, 28 mm, 33 mm, etc., or in sizeswhich are chosen as a matter of design or operator preference.

FIGS. 31 and 32 illustrate push-pull cap 224 which is made separate andintegral, respectively, with a valveless PIBA cap. Instead of channel80, at its end proximate the medication bottle, being sized to fit overa Baxa™ or Baxa™-equivalent manufacturer-supplied medication containercap, it is instead sized to fit within outer wall of stationary portion224A, which in turn is sized to fit within the open channel of a PIBAcap as shown. In FIG. 32, outer wall of stationary portion 224A is madeintegral with the inner channel of a PIBA cap, and/or is fitted withannular elastomeric rings to provide a press fit within the opening of amedication container.

FIG. 34 depicts a cap 226 comprising nozzle fitted with an integral orseparable valve 225 (typically, a duckbill valve, as shown in FIG. 34).The threaded inner wall of cap 226 may be provided in several standardsizes, such as 20 mm, 24 mm, 28 mm, 33 mm, etc., or in sizes which arechosen as a matter of design or operator preference. The outer wall ofcap 226 comprises two annular rings defining a groove to accept thefingers of the automated or semi-automated arms of the filling station,as will be described. Grooves provided on the outside of the medicationcontainer cap not only fit into the yoke of the syringe fillingapparatus and hold the medication bottle securely, but also locate themedication container on a reference center line. Grooves may also serveas a means to handle, move and position the medication container duringselection from a medication container library as will be described.

FIGS. 36-37 depict protective caps for the medication container capsdescribed herein. Each protective cap is designed to fit securely overand cover the nozzle of each of the medication container caps describedherein such that the medication container may be inverted without theattached protective cap falling off. For automated or semi-automatedsystems, as described herein, a separable cap can be used (see FIGS. 36Band 37B). For semi-automated systems only, a tethered protective cap maybe used (see FIGS. 36A and 37A).

Each adapter cap may be barcoded with a unique identifier number. Wherea tethered protective cap is used, the barcode may appear on theprotective cap instead of or in addition to on the adapter cap itself.In addition, molded surface features or textures may be provided on theouter surface of each cap to provide a gripping surface.

In addition, one skilled in the art should understand that theaftermarket valveless cap (e.g., Baxa Adapta-Cap™ bottle adapter) andthe adapter 2 as described above and in other embodiments of the presentinvention may essentially be combined in a single unitary structure.Specifically, the press-on container cap 214 may, if desired, beco-molded with the valve adapter cap 2 to form a unitary adapter cap. Inaddition, the valve adapter cap 2 may include one or two flanges toenable the container to be mechanically-handled for storage or transportin a fully-automated filling system such as shown and described inApplicant's co-pending U.S. patent application Ser. No. 13/236,577 filed19 Sep. 2011.

A preferred embodiment of the invention is now described with referenceto the PIBA with valve interface 212 of FIG. 5. Process and systemconfiguration variations specific to each of the container/syringeinterfaces are also described below.

The support fixture illustrated in FIG. 7A comprises a fixed-positioncontainer holding yoke 82 that engages the container/syringe interface210, 212, 214, 216 (see FIG. 5) suspending the assembly. Note that thefourteen syringe-filling closure variations containe/syringe interfaces210, 212, 214, 216, 220, 221, 226, and the Baxa™-type or PIBA variationsfor caps 223 and 224, both integral and separable, suitable for use withthe present system necessitate differently sized/shaped containerholding yokes 82, and for this reason yoke 82 may be removably-mountedto filling station 5 by thumb-screws or the like, allowing replacementwith different sizes and shapes. For example, FIG. 7C I shows acontainer holding yoke 82A with aperture configured to seat theprotruding stem of an interface 214, 216, while FIG. 7C II shows acontainer holding yoke 82B with aperture sized to seat the neck of acontainer in which an interface 210, 212 has been inserted. The platformthickness of yoke 82 is also important as valved versus valvelessclosures may require differing degrees of syringe nozzle insertion andso some yokes 82 may need to be very thin. The operator can choose theappropriately-configured yoke 82, and in all such cases the yoke 82facilitates easy frontal insertion of the container/syringe combinationand stably supports the container.

FIG. 7B is a composite view of a self-centering spring loaded bottlegripper assembly 82C used as an alternative to fixed yokes 82 of FIG.7A. The self-centering spring loaded bottle gripper assembly 82C of FIG.7B employs a pair of spring-loaded jaws 1002 slidably mounted on aball-slide track 1003 for slidable separation. A pair of trammel arms1004 are coupled from each jaw 1002 to a common pivot and therebymaintain symmetry of the jaws 1002 as they separate. The operator reststhe container neck onto the lips of jaws 1002 and pushes the containerstraight back, separating the spring-loaded jaws, until the jaws springtight about the container and it is gripped. Note that the jaws 1002 areformed to hook around the container and have a lowermost flange to serveas a reference to ensure that all syringes are uniformly located in thevertical dimension. Thus, gripping assembly 82C is advantageously betterable to withstand the shaking cycle and can fit into the limited spaceavailable.

The following table maps the container/syringe interface variations torequisite variations in the filling station 5 (FIG. 2 III 5) and pointsout the advantages of utilizing the self-sealing valve in the Baxa capor PIBA for tapered tip syringes (as shown in FIG. 38) and/or thepush-pull adapter cap 224 for Luer lock oral syringes (as shown in FIG.39) according to one or more embodiments of the present invention:

Need to invert Able to fill Filling station container and multiplesyringes 5 container syringe 180° at one time neck and then rotate Ableto without removing Container/Syringe positioning 180° after shake atfill container from fill No. Interface device filling syringe? station?station? 1 valve-less press in Yoke 82B Yes No No bottle adapter (FIG.7C II) (PIBA) 2 self sealing PIBA Yoke 82B No Yes Yes (SSPIBA) with an(FIG. 7C II) integral valve or self- centering jaws 82C (FIG. 7C III) 3valveless Baxa ™ Yoke 82A Yes No No or Baxa (FIG. 7C I) equivalent 4valved Baxa ™ or Yoke 82A No Yes Yes Baxa equivalent (FIG. 7C I) orself-centering jaws 82C (FIG. 7C III) 5 Valved self- Yoke 82D No Yes Yessealing two-piece (FIG. 7C IV) 220 or self- centering jaws 82C (FIG. 7CIII) 6 Valved self- Yoke 82D No Yes Yes sealing one-piece (FIG. 7C IV)221 or self- centering jaws 82C (FIG. 7C III) 7 Baxa ™ or Baxa Yoke 82AYes No No equivalent (FIG. 7C I) modified with non-integral push-in tipfor Luer lock oral syringes 8 PIBA modified Yoke 82B Yes No No withnon-integral (FIG. 7C II) push-in tip for Luer lock oral syringes 9Baxa ™ or Baxa Yoke 82A No Yes Yes equivalent with grooved modified withblock 400 non-integral (FIG. 41) push-pull cap 10 Baxa ™ or Baxa Yoke82A No Yes Yes equivalent with with grooved integral push-pull block 400cap (FIG. 41) 11 PIBA modified Yoke 82B No Yes Yes with non-integralwith grooved push-pull cap block 400 (FIG. 41) 12 PIBA with Yoke 82B NoYes Yes integral push-pull with grooved cap block 400 (FIG. 41) 13Valved common (Not shown) No Yes Yes inner diameter cap with groovedrings 14 PIBA retrofit with Yoke 82B No Yes Yes integral valve (FIG. 7CII) or self- centering jaws 82C (FIG. 7C III)

With reference to FIGS. 7A and 7D, upper, middle, and lower syringegripping arms 110, 111 i and 112 are staged in a vertical orientationthat will allow the selected syringe S to be easily slid into the fillzone, with plunger lifting arm 128 fully retracted. As different syringesizes have different exterior dimensions, the vertical orientation ofsyringe gripping arms 110, 111 and 112 may be adjusted prior to syringeinsertion to ensure that the syringe body can easily fit between themedication container and middle arm 111, which, as will be described,rests below the hilt or flange of the syringe. The syringe S isconnected to the medication container and both are held by yoke 82. Oncethe medicine container and syringe S are in place, and the start buttonis pressed, a guard is closed around the filling station, or by someother signal from the processor, a pair of syringe finger grippers 78close about the syringe S and hold it securely. Syringe finger grippers78 are air operated for opening and closing, or may optionally beservo-driven, and have a servo-operated mount which moves the fingers tothe center of the body of the syringe. This feature advantageouslyensures that the syringe tip is exactly on center with the yoke, assyringe tip to body eccentricity varies on syringes sized from 10 mL to60 mL. For syringe sizes between 0 mL and 60 mL, the tip of the syringeis eccentric to the body diameter, whereas on syringe sizes from 0.5 mLto 5 mL, the tip is concentric on the body diameter. The in and outmotion of the servo mount locates the grippers 78 to grip the center ofthe syringe body so that the center of the tip is always on center withthe yoke, regardless of its eccentricity to the body of the syringe.Additionally, a bottle holder platform 79 lowers to sandwich themedicine container against the container holding yoke 82. The bottleholder platform 79 has an aperture 791 through it and a scanner 121 ismounted above the aperture 791 to read the machine readable label on thebottom of the container 104.

An articulating syringe locator guide 81 (FIG. 7A) comprises a pair ofoffset fingers on a bracket that push against syringe finger flanges,effectively rotating the syringe to a known orientation. This ensuresthat all offset-tip syringes (nozzle offset from center axis) are inproper orientation for filling. One skilled in the art should understandthat the syringe locator collar 81 is not required for concentric tippedsyringes and may be articulated out of the way.

Once in the fill position in loading station 70 with syringe fingergrippers 78 closed around it, the syringe S is engaged by the upper 110,middle 111 and lower 112 arms, and a plunger lifting arm 128 thatextends upward from below, all of which collectively grip and operatethe syringe S in order to effectuate the filling process as describedbelow.

The syringe locator guide 81 withdraws to its home position. Upper arm110 lowers and middle arm 111 raises to close on the syringe body hiltor flange (see FIG. 19 for detailed view). This creates a sandwichingeffect to hold the body of syringe S securely. Lower arm 112 then movesdownward onto the upper side of the syringe plunger disc and plungerlifting arm 128 rises to a position just under the syringe plunger, thusworking in concert with lower arm 112 to create a sandwiching effect onthe syringe plunger disc captured between them. Upon command from theoperator or programmer, arm 112 and arm 128 work in concert to performpriming and/or filling of the syringe S. The use of both arm 112 and arm128 allow the filling station to exert both a pushing and a pullingeffect on the syringe plunger as the program dictates, thus allowingbetter control of the plunger location during both priming and filling.Upper and middle arms 110 and 111 may also work in concert to pushsyringe S further upward towards the medication container as necessaryto ensure that the closure of the medication container hasn't relaxedits fit with the tip of syringe S. The priming sequence is determined bysyringe size and viscosity of medicine to be filled. After priming iscomplete and with the piston all the way up, the piston is then pulleddownward to fill with the correct dose.

As described in more detail below, in a preferred embodiment, arms 110,111, 112 (FIG. 26) protrude vertically from the horizontal base of thefilling station 5 (FIG. 2), at which point they are sealed withwaterproof bushings, and terminate with at least onehorizontally-oriented curvilinear jaw. The watertight seal between thevertically oriented syringe filling arms 110, 111, 112 and thehorizontal base of the filling station 5 advantageously prevents liquids(such as medication from medication container 4) from being able tointer the interior of filling station 5. This curvilinear embodiment isthus preferred over the herein described horizontal arms having straightfingers wherein the horizontal arms 110, 111 and 112 must articulatevertically through one or more open vertical slots in the vertical backof filling station 5 (see FIG. 7A). The watertight seal and verticalorientation of curvilinear arms 110, 111, 112 is accomplished via thehorizontally-oriented curvilinear jaw, which is able to grip variousportions of the syringe S through a rotational motion of syringegripping arms 110, 111, 112 and withdraw the plunger of the syringe Swith vertical motion of syringe gripping arms 10, 111, 112.

As stated in the foregoing Table the yoke 82 will vary depending on thesyringe interface variation. Specifically, the OEM/Baxa cap 214 willrequire yoke 82A (FIG. 7C I), the OEM/Baxa cap with self-sealing valve216 will require Yoke 82A (FIG. 7C I), the valveless PIBA 210 willrequire yoke 82B (FIG. 7C II), the PIBA with self sealing valve 212 willrequire the adjustable clamping device 82C (FIG. 7C III), the Luer-typesyringe adapter tip 223 will require the adjustable clamping device 82C(FIG. 7C III) or yoke 82A (FIG. 7C I), push-pull cap 224 and thethreaded cap with automation grooves and valve will both require theadjustable clamping device 82C (FIG. 7C III).

The invention relies on a conventional network architecture whichincludes a local OSPS (Oral Syringe Packaging System) computer. The OSPScomputer is interfaced to a hospital host computer and receives oralsyringe prescription instructions therefrom (however, the OSPS systemmay be used as a stand-alone unit independent of any interface withanother computer). In the majority of circumstances, physicians submitprescriptions for oral syringes electronically to the hospital hostcomputer and these prescriptions are communicated to the OSPS computerfor fulfillment. The interface serves to parse/extract those oralmedication prescriptions from all prescriptions submitted.

The local OSPS computer is programmed to know what must occur at eachstation and monitors to ensure that each step of the process iscompleted satisfactorily and that all decision rules are complied with.The local OSPS computer software implements a Medication ContainerOrientation and Log-In Process for semi-automated preparation andstorage of bulk medicine containers to be used in filling and packagingoral syringes, and a Batch Fulfillment Process for semi-automatedfilling and packaging of oral syringes using the stored bulk medicinecontainers. In general terms, the semi-automated Medication ContainerOrientation and Log-In Process comprises the following steps:

a. Pharmacy technician (operator) removes the manufacturer's cap fromthe bulk medicine container received from the pharmaceuticalmanufacturer and installs one of several possible container/syringeinterface variations (as described above and below), in all such casesfacilitating insertion of an oral syringe nozzle into the container. Thepresent system is adaptable to filling syringes with each interfacevariation. The system may include an optional motorized capper/decapperstation to assist with the removal of the manufacturer's cap and theapplication of a threaded or PIBA interface.

b. Variable information such as container fill size, manufacturer'sexpiration date, and product lot number are entered into the OSPScomputer automatically as much as possible by bar code scan, or manuallyby the Pharmacy Technician under the supervision of the Pharmacist.First, the software guides the operator to scan the manufacturer'sbarcode label. However, the barcoded information is often incomplete.Any missing variable information such as container fill size,manufacturer's expiration date, and product lot number can be derivedand manually entered into the OSPS computer by the Pharmacy Technician.

c. If needed, the OSPS computer instructs the Pharmacy Technician whichof the container/syringe interfaces to select for recapping themedication container. The OSPS obtains this information from themedication database. In addition, the OSPS may direct the storagelocation of the correct size container/syringe interface to illuminate,unlock, or the like, as described in further detail below.

d. The OSPS computer auto-assigns an expiration date to the medicationcontainer based on either the manufacturer's expiration date or theexpiration date defined by pharmacy policy. The pharmacy expiration datepolicy is determined by the date the container is opened at themedication container log in station plus the number of days thePharmacist determines that the medication should expire. The OSPScomputer uses the date that is the soonest to determine the effectivemedication container expiration date.

e. Software automatically prints a new unique 2D barcode label.

f. The 2D barcode label is placed on the center of the base of thecontainer.

g. Software guides the operator to rescan the manufacturer's barcode onthe container label and the 2D barcode on the base of the container.

h. If scanning checks, the software guides the operator to place themedication container in a particular (logged) storage facility location.

The semi-automated Batch Fulfillment Process for any of the self-sealingcaps described herein comprises the following steps:

a. The software guides the operator to retrieve the medication containerfrom a particular (logged) storage facility location (the medicationcontainer may previously be logged according to the method describedherein with respect to the Medication Container Orientation and LoginStation).

b. The operator loads the medication container into the fill station.

c. The 2D barcode on the medicine container bottom is scanned to makesure that all medication issues relating to that medicine container havebeen addressed, including correct medication, refrigeration, expirationand light-sensitive storage.

d. The software guides the operator to pick a syringe of the propercolor and size.

e. The operator places the syringe in a syringe size/color station thatverifies that the proper size and color syringe has been selected.

f. If the syringe size/color inspection passes, the softwareautomatically prints a label for the syringe, and the operator manuallyapplies the label to the syringe. Alternatively, a semiautomatic flaglabeler may be used, as described in more detail below.

g. The label is rescanned to ensure that the information is readable andcorrect.

h. The operator scans the 2D barcode on the syringe at the fillingstation.

i. If needed, the medication container is shaken for the duration,intensity and interval(s) required by the shaking mechanism to which thecontainer is attached.

j. The operator positions the syringe at the filling station.

k. The system/software automatically fills the syringe from medicine inmedication container as described in more detail above and below.

l. The operator caps filled syringe at optional semi-automatic capper.

m. The operator scans the syringe at the optional fill inspectionstation.

n. The system automatically inspects the syringe at an optional visualinspection station for proper weight and/or volume.

o. The operator scans the syringe at the bagging station.

p. The system/software automatically prints bag that the syringe will bepackaged in.

q. The software automatically scans the printing on the bag to make surethat it is correct.

r. The operator places the syringe in the bag at the bagging station,and the system confirms that the syringe was placed in the bag and sealsthe bag with the syringe in it.

All medication containers and medicines in those containers that havebeen logged in, each size syringe, each size container/syringeinterface, the syringe labels, syringe bags, print media, etc. areautomatically inventoried. As an item is used or consumed, an accountingof the amount of that item remaining is maintained.

Via the 2D barcodes on each syringe and medication container and thescanning operations at each station, Track, Trace and Validationsoftware monitors and documents the entire process from the prescriptionapproval by the pharmacist, log-in of the medication container througheach step of the packaging process to ensure that the syringe is filledand packaged correctly. The Track, Trace and Validation software alsotracks the operation of the equipment used in the process to ensure thateach piece of equipment is functioning properly, and provides errormessages when any piece of equipment malfunctions. This aspect of theinvention further results in the formation of an “audit” record of allmachinery involved in the processes so that an operator, pharmacist, ortechnician may review a log of the machinery's operations to performtroubleshooting and/or quality checks.

FIG. 1 is a high level flow chart of the overall method of theinvention. The following method steps are performed semi-automaticallywith some manual intervention by or interaction with an operator forfilling patient-specific oral syringes on a just-in-time basis. Notethat “semi-automatic” necessarily entails manualintervention/interaction which has a propensity for introducingmistakes. The present method and apparatus is specifically designed toavoid mistakes and maintains comprehensive track-and-trace validation ofeach manual step:

At step 705 a physician writes an oral medicine prescription which iselectronically entered into existing hospital host computer (as allprescriptions are so logged).

At step 710 the existing hospital host computer communicates the oralmedicine prescription to the hospital pharmacy for approval. Apharmacist will typically review it.

If approved by the pharmacist, then at step 715 the prescription istransmitted the local computer of the OSPS (Oral Syringe PackagingSystem) of the present invention. The oral syringe prescription is addedto a batch fulfillment queue at the local OSPS computer. As describedbelow the queue is multi-sorted so that all prescriptions for aparticular type of medicine (e.g., Acetaminophen, cough syrup, etc.) canbe fulfilled together, and at periods throughout the day an operator mayrun a batch fulfillment queue (typically batches are run a few timeseach day).

At commencement of batch fulfillment, the OSPS system preferably guidesthe operator in retrieving the appropriate medication container fromOSPS storage (as will be described). Such guidance presupposes that alibrary of medicine containers is maintained and that each such medicinecontainer be logged into the OSPS system so that its location andcontents are known to the local OSPS computer. Consequently, as aprecursor to batch fulfillment each new medication container is loggedinto OSPS storage by a barcode, RFID scan or similar identification scan(e.g., of the manufacturer's barcode) as described above. Themanufacturer-supplied medicine container cap must be replaced, retrofit,or supplied by the manufacturer in a form that enables an oral syringeto enter a center hole and withdraw an amount of liquid from themedication container while the medication container is positioned upsidedown, and the syringe S then removed from the container without leaking.There are fourteen container/syringe interface variations suitable foruse with the present system (see FIGS. 5, 27-34 and 44 and the detaileddescriptions associated with them). All this occurs at step 720 (FIG.1).

At step 725, based on the medication container login, the OSPS systemguides the operator in properly storing the new medication container.The OSPS system (as described below) includes separate storage locationsfor three types of medication containers: Location 1—No Special Handlingof container; Location 2—Refrigeration Required; Location 3—LightSensitive medication container (refer to FIG. 2 II, refs a-c). Eachstorage compartment within each location may be enclosed by amagnetically-actuable door so that access to each location may beelectronically controlled by the local OSPS computer. Alternately, eachstorage compartment within each location may be illuminated by an LEDlight, so that access to the proper location may be electronicallyguided by illumination of the proper LED. As another alternative, eachstorage compartment within each location may be equipped with a lightcurtain so that the local OSPS computer can monitor access to the properlocation. All these and other suitable forms of user-guidance/selectionare considered to be within the scope and spirit of the presentinvention. In all such cases, the end result is an OSPS storage libraryof different oral medicines in their bulk containers, each properlylogged in and stored in its corresponding storage location a-c.

Similarly, at step 740 an inventory of packaging materials ismaintained, including empty syringes in an array of sizes, syringe caps,labels (for barcodes), and ink foil printer ribbon.

In support of the OSPS system, at step 730 a comprehensive medicationdatabase is maintained at the OSPS computer. The OSPS medicationdatabase includes the following:

1. Medication Information:

-   -   a. Medication name.    -   b. Manufacturers barcode number.    -   c. Written information that corresponds to manufacturer's        barcode number.    -   d. Whether medication needs to be shaken, if so, the frequency,        intensity, and duration.    -   e. Whether the medication needs to be refrigerated, if so        refrigeration policy required.    -   f. Whether the medication is light sensitive, if so light        sensitive protection required.        2. Product information (pertaining to individualized medication        containers logged in):    -   a. The OSPS 2D barcode number assigned to that specific        container. The label containing this information is placed on        the base of the container.    -   b. Fill size of that container in cubic centimeters (cc) or        milliliters (ml).    -   c. Current amount of product remaining in that container after        deducting for previous fills extracted by the syringes.    -   d. Manufacturer's Expiration Date.    -   e. Date the medication container is logged-in at the Medication        Container Log-In Orientation System.    -   f. Pharmacy Policy Expiration Date. This is the container open        date plus number of days before container expires (determined by        pharmacist).    -   g. Effective Expiration Date. This is the soonest of the        manufacturer's expiration date or the date that the container is        open plus the number of days that the open container will expire        (i.e., Pharmacy Policy Expiration Date).

Given all of the foregoing, at step 750 an operator may at anyconvenient time commence the batch fulfillment process. The detailedsubsteps of the batch fulfillment process 750 are described below andillustrated in the block diagram of FIG. 3.

Referring back to FIG. 1, after each oral syringe has been filled andpackaged during batch fulfillment 750, it is inspected and eitherrejected at step 760 or approved at step 770.

The above-described method is herein implemented in several detailedembodiments of a system suitable for preparing patient-specific oralsyringe doses. Various alternate embodiments of the invention may omitselected steps (and their performance station) where such is/are notrequired. The needs of the operating institution and the cost aspect ofautomating certain steps may direct which steps/stations (if any) are tobe performed manually by an operator interfacing with the apparatus andwhich may be automated.

A presently-preferred embodiment of the physical system componentry isdescribed below with reference to FIG. 2.

As seen in FIG. 2, the pharmacy automation system 100 for packaging oralsyringes generally comprises a standalone Medication Container Login &Orientation Station 11, with an included array of container/syringeinterface storage bins 12. In addition, a proximate or remote StorageFacility II is provided for storing all logged in medication containers,with separate locations for the three types of medication containers:(a) Location 1—No Special Handling of container; (b) Location2—Refrigeration Required; (c) Location 3—Light Sensitive medicationcontainer. The final component of the system includes the syringepackaging line III.

In an alternate embodiment of the present invention, Storage Facility IIof FIG. 2 may be substituted with an automated medication storagecabinet (AMSC) with rotary shelves, such as the commercially availableMedCarousel® sold by McKesson Automation Solutions, or similar modelssold by TALYST, OMNICELL, SAPIENT AND US MEZZANINES, AMSC units such asthese are currently being utilized in hospital pharmacies. These systemsautomate the medication management process from ordering the medication,stocking the medication on the system's rotating shelves, and presentingthe medication to the pharmacy technician at the time the medicationneeds to be utilized to fill the prescription on the OSPS. Therefore,the accuracy and efficiency of medication dispensing and inventorymanagement is increased. Aided by rotating shelves, pick to-light, barcode scanning and comprehensive integrated workflow software, the AMSCsystems guide the pharmacist to medication storage locations, improvingpicking speed and accuracy. AMSC systems such as the MedCarousel® canhandle storage of refrigerated as well as non-refrigerated medicines.

In conjunction with the OSPS, an AMSC system would operate as follows:

-   -   1. Two AMSC systems would be utilized, one for non-refrigerated        medications and the other for refrigerated medications. The        containers that require light protection would be stored on the        non-refrigerated AMSC system.    -   2. After the medication container was oriented and logged in to        the OSPS, the AMSC would assign a location to store that        medication.    -   3. The 2D bar code on the container would be scanned.    -   4. The shelf that the medication was to be stored on would be        positioned in front of the pharmacy technician. A light would        appear over the location on the shelf on which the medication        was to be stored.    -   5. The pharmacy technician would place the medication at that        location.    -   6. At the start of the next OSPS production run, the OSPS would        list the prescriptions to be filled by medication. This        information would be sent to the AMSC(s).    -   7. The pharmacy technician would then remove the medication        containers that are presented and scan them. The medication        containers would be kept in the same order in which they are        removed by the technician. This order corresponds to the order        in which the medication will be used to fill syringes on the        OSPS.    -   8. After the production run, the medication containers would be        returned to the AMSC(s) in the same order in which they were        removed therefrom. The pharmacy technician would scan the        medication containers. The AMSC(s) would present the pharmacy        technician with the proper shelf and light the position to which        the medication container should be returned. The pharmacy        technician would return the medication container to the        indicated location in the AMSC(s).

A syringe storage bin 3 (see FIG. 2 III) is provided for storage ofempty syringes, and a syringe label printer and labeler station 4 (seeFIG. 2 III) is also provided. Next, a syringe size/color inspectionstation 11 is provided. These are followed by a syringe filling station5 with integrated medication container shaker assembly 820 (as describedbelow). An alternative embodiment is a stand-alone shaking station.

At the filling station 5 the medication container with container/syringeinterface 212 or 216 (see FIG. 5) is manually inverted and inserted. Anoverhead clamp lowers against the topside base of the medicine containerto clamp the container against its holder. This provides an opportunityto inspect the medication container's 2D barcode (located in the centerof the container's bottom) via the Lexan™ disc found in platform 79 (seeFIG. 7A) to verify that it is the correct medication. The medicationcontainer is shaken if necessary. The syringe's 2D barcode is inspectedand, if correct, the syringe is inserted into the medication containervia the container/syringe interface. A plurality of servo-driven fingers(to be described) grip and stabilize the syringe S. The fingersmanipulate the syringe plunger to prime and fill the syringe. When allsyringes have been filled with the medication, the medication containeris returned to storage. This process continues until all syringes forthat prescription production run have been filled.

Next, a semi-automated capping station 8 is used to place a cap (fedfrom an inclined capping chute 149) on the open tip of the filledsyringe.

After each syringe S is filled and capped it is loaded into a visioninspection station 9 which verifies the presence of the cap, the pistonposition within the syringe, that the syringe is filled with medication,and that an excessive number of air bubbles are not present.

Lastly a bag printing and sealing station 7 bags the filled syringe in abarcoded bag.

The purpose and function of each of the foregoing stations 1-5, 7-9, and11 (see FIG. 2 I, II, III) will become clearer in the context of adetailed description of the Medication Container Orientation and Log-InProcess (step 720), and Batch Fulfillment Process (step 750).

Medication Container Orientation and Log-in Process (step 720)

The OSPS system guides the operator in properly equipping and storingeach bulk medication container. As described above, themanufacturer-supplied medicine container cap must be replaced, retrofit,or supplied by the manufacturer in a form that enables an oral syringeto enter a center hole and withdraw an amount of liquid from themedication container while the medication container is positioned upsidedown, and the syringe S then removed from the container without leaking.Thus, at step 720 (FIG. 1) the manufacturer-supplied medicine containercap may need to be provided to specification, or replaced or retrofittedwith a container/syringe interface to provide a penetrable orifice. Asdescribed more fully below the retrofit may be accomplished in a numberof ways. Thus, the present invention contemplates fourteen (14)container/syringe interface variations: (1) a valve-less press in bottleadapter (PIBA) 210; (2) a self sealing PIBA (SSPIBA) 212 with anintegral valve (typically, either a linear or a Z-shaped slit) 213; (3)a standard manufacturer-supplied (Baxa™ or Baxa equivalent) valve-lessmedicine container cap 214 with opening; (4) a modifiedmanufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap216 that is retrofit to include an integral valve 225 (typically, aduckbill valve); (5) a two-piece cap comprising an outer portion 220with a common outer diameter for all standard sizes of medicationcontainer, and a self-sealing insert 212; (6) a cap 221 comprising acommon outer diameter for all standard sizes of medication container andhaving an integral self-sealing insert 212; (7) a modifiedmanufacturer-supplied (Baxa™ or Baxa equivalent) medicine container cap214 that is retrofit to include a non-integral push-in tip 223 forinterfacing with Luer lock oral syringes; (8) a modified PIBA 210 thatis retrofit to include a non-integral push-in tip 223 for interfacingwith Luer lock oral syringes; (9) a modified manufacturer-supplied(Baxa™ or Baxa equivalent) medicine container cap 214 that is fittedwith a push-pull cap 224 for interfacing with Luer lock oral syringes;(10) a modified manufacturer-supplied (Baxa™ or Baxa equivalent)medicine container cap 214 that is retrofit with an integral push-pullcap 224 for interfacing with Luer lock oral syringes; (11) a modifiedPIBA 210 that is fitted with a push-pull cap 224 for interfacing withLuer lock oral syringes; (12) a modified PIBA 210 that is retrofit withan integral push-pull cap 224 for interfacing with Luer lock oralsyringes; (13) a cap 226 comprising a common inner diameter for allstandard sizes of medication container, fitted with an integral orseparable valve 225 (typically, a duckbill valve), and having groovedrings to facilitate handling, positioning, etc. by the system accordingto the present invention; and/or (14) a valveless PIBA that is retrofitto include an integral valve 225 (typically, a duckbill valve). Again,all fourteen variations as shown in FIGS. 5, 27-32 and 34 and 44 aredescribed below in detail above.

It is envisioned that medication containers may be provided to thehospital pharmacy for use with the present system in such a way thatwill minimize or possibly eliminate any need for the MedicationContainer Orientation and Log-In Process (step 720). For example,medication containers may be provided for use with one or more of thefollowing features:

-   -   1) standardized caps with self-sealing valve (such as, for        example, the above-referenced Baxa™ or Baxa-equivalent medicine        container cap with penetrable opening);    -   2) standardized containers;    -   3) barcoded or RFID-coded containers that already contain the        information that a pharmacy technician would otherwise need to        input during the Medication Container Orientation and Log-In        Process (step 720); and/or    -   4) any other means of providing the information that a pharmacy        technician would otherwise need to input during the Medication        Container Orientation and Log-In Process to the OSPS database        and system, such as, i.e., via the Internet.

A combination of all three features listed above would minimize oreliminate the need for the Medication Container Orientation and Log-InProcess (step 720). However, for purposes of complete description itwill be assumed that such features are lacking in OEM-suppliedmedication containers and so the Medication Container Orientation andLog-In Process (step 720) will herein be described in detail.

Referring now to FIG. 4 which is a flow diagram of the Log-In processfor the valved PIBA 212 (see FIG. 5), at step 900, medication containersare received from a contract packager or pharmaceutical manufacturer.

At step 910, medication containers are delivered to the OSPS MedicationContainer Login & Orientation Station 1 (FIG. 2).

At step 915 the pharmacist and operator logs into the local OSPScomputer.

At step 925 the manufacturer-provided medication container barcode isscanned. Variable information is entered into the system by the pharmacytechnician.

At step 935, the labeler shown at the Medication Container Login &Orientation Station 1 (see FIG. 2 I) generates a 2D barcode label whichincludes the location that the medication container is to be stored at.The 2D bar code is manually placed on the bottom of the container (or onthe container/syringe interface) at step 945.

At step 940, the bar code label is automatically scanned/inspectedimmediately after printing to verify that its contents are correct andthe bar code ID is stored in the OSPS database.

At step 945, the bar code label is adhered to the base (bottom) of thecontainer.

At step 950, both the 2D bar code placed on the base of the containerand the pharmaceutical manufacturer's barcode are scanned using ascanner resident at the Medication Container Login & Orientation Station1 and the manufacturer's bar code on the medication container label arescanned to verify that the correct 2D bar code was placed on the base ofthe container.

At step 955 all general and container specific information, inclusive ofProduct Information and label photograph, is recorded in the local OSPScomputer database, including the storage location of the bulk container.

At step 960, the OSPS local computer assigns an expiration date to themedication container. The expiration date is predetermined by pharmacypolicy. The pharmacy policy expiration date is determined by the datethe container is opened at the Medication Container Log In Station 1plus some number of days after which the Pharmacist determines that themedication should expire.

At step 961, the medication container cap is removed from the containerby the operator and is set aside for later reuse.

At step 962, the OSPS local computer instructs the pharmacy technicianregarding which size adapter cap to obtain and insert into the containerneck. To guide the operator, the box 12 containing the correct sizeadapter cap is preferably illuminated as shown in FIG. 2.

At step 963, the pharmacy technician inserts the adapter cap onto themedication container. In some embodiments, the original medicationcontainer cap from step 961 may be replaced on the medication container.

At step 965, the operator manually stores the medication container inthe location specified by the OSPS local computer (see FIG. 2 II).

At step 970 if the container is to be stored in the refrigerator, anoptional log-in/log-out control system and procedure is available toverify if the container was refrigerated satisfactorily (see FIG. 2 IIb). This way, if the container is outside of the refrigerated storagearea more than a specific number of minutes the OSPS local computer willnot permit the syringe to be filled from that container, and will alertthe Pharmacy Technician to remove and discard that container.

At step 975 if the container is to be stored in a light protectedstorage area, an optional log-in/log-out control system and procedure isavailable to verify if the container was stored appropriately (see FIG.2 II c). This way, if the container is outside of the light protectedstorage area more than a specific number of minutes the OSPS localcomputer will not permit the syringe to be filled from that container,and will alert the Pharmacy Technician to remove and discard thatcontainer.

Batch Fulfillment Process 750 (FIGS. 1-3)

With reference both to FIGS. 2-3, at step 800 a pharmacist must log intothe OSPS local computer to use the system.

At step 810, the pharmacist selects the desired OSPS operational mode.Currently four modes of operation are envisioned:

1. Patient Specific—Hospital Directed

-   -   a. The Doctor writes the prescription and enters it into the        Hospital Host Computer System.    -   b. The prescription is reviewed by the Pharmacist. If it is        okay, the prescription is sent to the Local OSPS Computer where        it is batched. Batches will typically be run 2-3 times a day.    -   c. The Local OSPS Computer first sorts all the batched        prescriptions by type of medication. The order of the queue may        be in the discretion of the pharmacist (i.e., alphabetically by        medication name).    -   d. The prescriptions are then sorted by size of fill from        smallest to largest. The total amount of each medication        required for that batch run is totaled. The Local OSPS Computer        checks to ensure that there is a sufficient amount of product        for each medication required to complete the batch.    -   e. If a doctor orders, for a single patient, multiple same doses        of the same medication to be administered at different times,        all doses can be filled together during a single production run        or in separate production runs at the discretion of the        Pharmacist. In a preferred embodiment, all prescriptions for one        medication are filled at the same time, followed by all        prescriptions for the next medication, etc.

2. STAT (Rush Order)—Hospital Directed

-   -   a. The Doctor writes the prescription and enters it into the        Hospital Host Computer System.    -   b. The prescription is reviewed by the Pharmacist.    -   c. The prescription order indicates that the prescription needs        to be administered soon to the patient.    -   d. If the OSPS System 100 is currently being used, the        Pharmacist can decide to either stop all current prescriptions        being packaged or wait until completion. Either way, the Local        OSPS Computer processes the singular rush order.

3. Medication Specific—Pharmacy Directed

-   -   a. This mode allows production-scale filling of a large number        of syringes with the same medicine and the same fill volume.        Some medication will need to be inventoried in advance of the        Doctor's prescription. This mode provides the pharmacist with        the opportunity to package certain liquid oral products such as        vitamins and popular standard dose medications on a more        cost-effective basis than buying them already pre-packaged,    -   b. The Pharmacist will manually enter in a production order for        the medication into the Local OSPS Computer.    -   c. The Pharmacist will specify the medication name, size of        fill, the information that will go onto the syringe label, the        information that will go onto the bag that the syringe is        packaged in, and the amount of syringes that are to be packaged        for that production run.

4. Manual—Pharmacy Directed

-   -   a. Not all hospitals have an existing electronic prescription        system installed that permits the electronic transmission of the        Doctor's prescription to the hospital pharmacy. Consequently,        the OSPS can be operated on a manual basis whereby the        prescriptions are entered into the system under the Pharmacist's        supervision.

One skilled in the art should understand that other operational modesare possible, for example, a Patient Priority mode in which allmedications/oral prescriptions for a specific patient are processedsequentially before moving on to the next patient. The invention isherein described in the context of Patient Specific—Hospital DirectedMode which is the most typical mode of operation.

At step 811, by way of example, Patient Specific—Hospital Directed isselected and the process is herein described accordingly.

At step 815 an operator (pharmacy technician) logs in.

At step 820 the OSPS local computer directs the operator to select theappropriate medicine container from Storage Facility 2 (see FIG. 2 II),and an appropriate syringe from storage bin 3 (FIG. 2 III).

At step 825, the operator retrieves the appropriate medicine containerfrom Storage Facility 2 (see FIG. 2 II) (under system guidance) andinverts and installs it at the syringe filling station 5 (see FIG. 2III).

At step 826, the barcode on the bottom of the container is scanned tomake sure that all medication-related issues have been satisfied(refrigeration, shaking, light-sensitive storage, expiration, etc.).

At step 830, the pharmacy technician places the syringe S on theinspection station cradle (see FIG. 2, ref. 11). Alternatively, theinspection station may be omitted and the syringe may be inspected atthe labeling station 4.

At step 835, the system automatically inspects the syringe for propersize based on a syringe body measurement (described below), to verifythat the correct syringe has been selected. Proper color of color-codedsyringes is also verified.

At step 837, the operator prints a syringe label at syringe labelprinter and labeler station 4 indicating in both human and machinereadable forms (i.e. text, barcode or RFID tag) the type, concentration,expiration, etc. of the medication it will contain. The label includes abar code (preferably a 2D barcode though other labels such as RFID maybe used. The label is adhered to the syringe barrel. Alternatively, asemi-automatic flag labeler is used as described below.

After printing the label per step 837, at step 838 the label isinspected to ensure that its content is correct.

At step 839, the label is affixed to the syringe S (where asemi-automatic flag labeler is used, the flag is adhered to the syringeS automatically by the labeler).

At step 840, the operator manually places the syringe at the syringefilling station 5 (FIG. 2).

At step 841 (if required), the shaking mechanism 820 (FIG. 2 III) shakesthe medication container before any medication is drawn from it into thesyringe.

At step 845, the syringe is filled at the filling station 5. The OSPSsystem automatically primes and fills the syringe with the medicine byinsertion and withdrawal of the plunger.

At step 848, the syringe is capped at the semi-automatic capping station8. The capping station caps the syringe and presents it to the operator.

At step 850, the operator positions the filled syringe S at the visioninspection station 9 (FIG. 2, III) and at step 855 the syringe isinspected for correct vision metrics. These actions are logged.

At step 860 a syringe bag is printed/barcoded at bag printing andsealing station 7 (FIG. 2, III), and at step 861 the system verifies thebag is printed correctly. If so, the operator is permitted to insert thefilled/capped syringe S into the barcoded/labeled bag.

At step 865 the pharmacy technician inserts the syringe S into the bag(FIG. 2, III).

At step 870 the syringe bag is sealed at the bag printing/sealingstation 7. The packaged syringe can then be distributed to the patient.

As mentioned at Note 1 (FIG. 3), at each step of the above-describedprocess the OSPS system employs comprehensive track-and-traceinspection/validation of the syringe and, when required, the bulkmedication container, to insure that the packaging process is occurringcorrectly and to compile an audit trail of the current and pastlocations (and other information) for each syringe. If all process steps800-870 occur correctly, the syringe S is approved and made availablefor distribution to the patient (see FIG. 1, step 770).

If a process step fails then as seen at step 760 of FIG. 1 the syringeor medicine container is rejected (and barred from distribution to thepatient).

The core method and possible variations are herein implemented inseveral detailed embodiments of a system suitable for preparingpatient-specific doses of liquid medications into oral syringes on ajust-in-time basis. Various alternate embodiments of the invention mayomit selected steps (and their performance station) where such is/arenot required. The needs of the operating institution and the cost aspectof automating certain steps may direct which steps/stations (if any) areto be performed manually by an operator interfacing with the apparatusand which may be automated. For example, the syringe S handling can beaccomplished in numerous ways, the simplest option being described abovein regard to FIGS. 2-3. In this instance, one operator packages onesyringe at a time sequentially from syringe selection through baggingthat syringe S until each of the syringes S that need to be filled witha specific medication are packaged (see FIG. 2). However, severalsyringe handling variations are given below.

Alternative Syringe Handling Options

As mentioned above the handling of the syringes S on the packaging linecan be accomplished in numerous ways, the simplest option (Option 1)being described above with regard to FIG. 3. However, productivity ofthe packaging line can be increased using other syringe handlingvariations. Some of the alternate syringe handling options are asfollows:

Option 2—Similar to Option 1 but two operators process/package some orall of the syringes S at one time as a group, at each of three groupedstations, wherein a first operator processes/packages some or all of thesyringes S at one time at station 1, then moves to station 3 while asecond operator processes/packages some or all of the syringes S at onetime at station 2. As shown in FIG. 22B, for Option 2 a first group ofstations includes syringe selection from the syringe storage location 3,inspecting the syringe for size and color, and labeling the syringe. Asecond group of stations comprises filling and capping the syringe atsyringe filling station 5 and capping station 8. A third group ofstations comprises inspecting and bagging the syringe at visioninspection station 9 and bagging station 7. All of the syringes S thatare to be filled with the same medication would be processedcollectively at the first group of stations by operator 1 and thenplaced in a first receptacle to be picked up by the second operator.While this is taking place, operator 2 may begin to process some or allof the syringes from the first receptacle at the second group ofstations, placing processed syringes in a second receptacle. Whenoperator 1 has completed the tasks of selecting a syringe, verifyingthat it is correct, labeling the syringe and verifying that it waslabeled correctly, he or she may move to the third group of stations toprocess some or all of the syringes in the second receptacle until allof the syringes are packaged with the specific medication. Then the nextmedication would be packaged. To facilitate this grouped approach, as analternative, FIG. 22A shows a multiple syringe compartment tray whichslides along a track to shuttle multiple syringes S back and forth tosuccessive grouped stations and may be used in place of first and secondreceptacles.

Option 3—Similar to Option 1 but one operator processes/packages some orall of the syringes S at one time as a group, at each of three groupedstations before proceeding to the next grouped station. Similarly toOption 2, in Option 3 a first group of stations includes syringeselection from the syringe storage location 3, inspecting the syringefor size and color, and labeling the syringe. A second group of stationscomprises filling and capping the syringe at syringe filling station 5and capping station 8. A third group of stations comprises inspectingand bagging the syringe at vision inspection station 9 and baggingstation 7. All of the syringes S that are to be filled with the samemedication would be processed collectively at the first group ofstations 3, 4, then all of the syringes would be processed at the secondgroup of stations 5, 8, and then all of the syringes would be processedat the third group of stations 7, 9 until all of the syringes arepackaged with the specific medication. Then the next medication would bepackaged.

Option 4—Similar to Option 2 but three operators are utilized, one atthe first group of stations 3, 4, one at the second group of stations 5,8, and one at the third group of stations 7, 9. To facilitate this, acarousel conveyor 325 is shown in FIG. 23 with multiple trays 327, eachcontaining 3-5 syringe compartments per tray. The trays 327 rotatearound the carousel 325 past three operators positioned one per eachgroup of stations.

Option 5—Similar to Options 1, 2 and 3 but two operators are situatedaround a lazy Susan (carousel-like) disc 342, as shown in FIG. 24.Operator 1 selects, labels and inspects empty syringes S for size andcolor and places them in trays 343 located radially arranged on the disc342. Additionally Operator 1 collects the medication bottles and eitherstages them, or an upper tier 345 of the disc 342 retains them for thesecond operator.

Operator Two receives the syringes S and medication bottles via therotating disc 342 and performs the filling and capping at stations 5, 8,respectively. Operator Two may also do the filled syringe inspection atstation 9. At this point it may be necessary to opt for an OperatorThree to do the filled syringe inspection at station 9. Operator Two orOperator Three may then place the Filled, Capped and Inspected syringe Sonto the rotary disc 342 to be indexed back to Operator One for baggingat station 7.

Option 6—Similar to Option 4 however this system utilizes (3) operators.As seen in FIG. 25, Operator One inspects empty Syringes for size andcolor, applies a flag label to syringe S and places it on the lazy Susandisc 342 in trays 343. Operator Two, places the empty inspected syringeS into the filling station 5 and fills, caps and places them onto thedisc 342 for transport to Operator Three. Operator Three inspects thefilled syringe for correct dosage. The syringes S are then conveyed backto Operator One for bagging at station 7.

Referring back to FIG. 2, each station of the pharmacy automation system100 for oral syringes is described below in more detail.

Medication Container Login & Orientation Station 1

The first station in the process of the present invention is MedicationContainer Login & Orientation Station 1 (see FIG. 2 I) at which the bulkmedicine is prepared for use in the overall system 100. MedicationContainer Login & Orientation (MCLO) Station 1 is a standalone desk unitthat provides a facility for inputting needed information into the OSPSdatabase via scanner 95 and data entry terminal 96, apply barcodes asneeded via label printer 97, decap bulk containers 104 at optionalcapping/decapping station 93, refit and/or retrofit them as necessarywith a container/syringe interface (as will be described) atcapping/decapping station 93, and optionally photograph them using alabel photographing station 98. All of the scanner 95, data entryterminal 96, and label printer 97 are commercially available components.MCLO Station 1 is standalone so that it can be positioned as desired.Medicine for oral syringes is provided in liquid form in a containerwith a manufacturer-applied safety cap. An object of the presentinvention is to be able to insert a syringe nozzle into the containersto withdraw a proper dose of medicine into the syringe. To be able to dothis, manufacturers must supply a specialized cap or insert, or thepharmacy technician must replace or supplement the manufacturer-suppliedcap with a container/syringe interface.

Referring back to FIG. 2 I, at MCLO Station 1 a number of bins 12 areprovided for storing various sizes and configurations ofcontainer/syringe interfaces 210, 212, 214, 216, 220, 221, 226, and theBaxa™-type or PIBA variations for caps 223 and 224, both integral andseparable, (see FIGS. 5, 27-34 and 44) as needed to fit all standardcontainer sizes. As described above in steps 910 through 965 (FIG. 4),OSPS system 100 guidance for the manual container 104 selection processand return process (along with the container/syringe interface 210, 212,214, 216, 220, 221, 226, 223 and 224 and syringe S selections) may be“system-guided” as described above. Each container/syringe interfacestorage compartment 12 (see FIG. 2 I) may be enclosed by amagnetically-actuable door so that access to each location may beelectronically controlled by the local OSPS computer, or illuminated byan LED light, or equipped with a light curtain so that the local OSPScomputer can monitor access to the proper location.

OSPS system 100 guidance for the manual container 104 selection processemploys a software module that relies on all three of the informationcomponents stored in the OSPS system database: 1) product informationfrom the manufacturer or other external sources describing the medicinesand their containers (size, dose, handling requirements, etc.); 2)prescription-specific information from the hospital identifying theprescription details and patient to receive it; and 3) OSPS runtimeinformation such as the amount of medicine previously taken from a givenbulk container. The exact container 104 location is provided to theoperator via OSPS system 100 guidance who retrieves the container fromthe Storage facility 2. Again the Storage facility 2 may be fitted withmagnetic doors, LED lamps or light curtains either to compel the properselection, draw the operator's attention to it, or provide an alarm incase of a wrong selection.

In operation, and as described above with regard to FIG. 4 (medicationcontainer orientation and log-in process steps 961-963), the OEM caps onmedication containers 104 are manually removed and replaced with anapplicable adapter cap, i.e., a valved PIBA 212 (see FIG. 5). The OSPSlocal computer instructs the operator which of the valved adapter capsizes in storage bins 12 (FIG. 2) to select for insertion into themedication container 104 (step 963). The labeler 97 generates a 2Dbarcode label which includes the location of Storage facility 2 (seeFIG. 2 II) that the medication container 104 (see FIG. 2 I) is to bestored at. The operator places the 2D bar code on the bottom of themedicine container, and the 2D barcode is scanned by scanner 95, andoptionally photographed using a label photographing station 98. Allgeneral and container specific information derived by scanning orsupplemental data entry at data entry station 96 is recorded in thelocal OSPS computer database, including the storage location of the bulkcontainer 104 in Storage facility 2 and the expiration date of themedication container. The operator then manually stores the container inthe Storage facility 2 assigned by the OSPS computer. If the containeris to be stored in light protected storage 2 II c or refrigeratedstorage 2 II b the track-and-trace software ensures compliance. Later,when needed to fulfill a batch of oral syringe prescriptions an operatorwill select (with system guidance) a container 104 of the desiredmedicine from the Storage facility 2 with container/syringe interface210, 212, 214, 216, 220, 221, 226, 223 and 224, (see FIGS. 5, 27-34 and44) applied and load it into the filling station 5 where the 2D bar codelabel on its base is automatically scanned by scanner 121 at the fillingstation 5. The medicine is verified by the scanning as to propercontent, available fluid volume and other attributes before being filledat filling station 5.

A second station in the packaging process according to the presentinvention is a storage bin 3 (see FIG. 2 III) for storage of emptysyringes. The syringe storage 3 preferably incorporates a separatesyringe compartment for each size of syringe that the system anticipatesneeding in the course of a production run. Again, this manual selectionprocess (along with other manual selections) is “system-guided” asdefined above in respect to syringe S selection as well. As withmedicine container 104 selection, the software module ascertains fromthe patient-specific information the appropriate dose of medicine todetermine the specific syringe S size to retrieve. The location of thatsyringe S is ascertained from the database, and the exact syringe Slocation in syringe storage 3 is presented to the operator who retrievesit from the syringe storage 3. Again the syringe storage 3 may be fittedwith magnetic doors, LED lamps or light curtains either to compel theproper selection, draw the operator's attention to it, or provide analarm in case of a wrong selection. In still other embodiments thesyringe storage 3 selection may be semi-automated so that theappropriate syringe S is ejected to the operator under control of thelocal OSPS computer. The selection software module calculates the mostappropriate syringe S size based on the required prescriptioninformation dosage, the known volume of the syringe selections (thefollowing standardized oral syringe sizes: 0.5 ml, 1 ml, 3 ml, 5 ml, 10ml, 20 ml, 35 ml, 60 ml), identifies the syringe size to accommodate thefill volume of the prescription, and presents the syringe storage 3location to the operator who retrieves the syringe from the propermagazine (with help of LED indicator, magnetic door, light curtain,ejection mechanism or otherwise).

A third station in the filling and packaging process is the syringesize/color inspection station 11 which verifies that the correct syringeS has been selected. The syringe size/color inspection station 11 isdescribed more fully below with regard to FIG. 15A.

The fourth station is a flag label printer/applicator 4. Afterdetermining that the syringe S is the proper size and color, theoperator inserts the syringe into syringe label printer/applicator 4. Asdescribed above relative to FIG. 3 (step 837), the operator prints asyringe label at syringe label printer 4. The labeler is incommunication with the local OSPS computer and automatically printsself-adhesive labels bearing information regarding the prescription suchas the eventual contents of the syringe (medicine type, concentration,dosage, expiration, scheduled administration, etc.) and its intendedrecipient (name, room number, etc.) along with a bar code identifying acentral record of this information in the OSPS database. The labelincludes a 2D barcode though other labels such as RFID may be used. Thelabel is inspected to verify the accuracy of the printed informationbefore it is attached to the syringe S. The label is supported by hingedarms of the applicator and held by vacuum pressure while the applicatoradvances to envelope the syringe barrel with the hinged arms comingtogether to join the label as a flag to the barrel of syringe S.Alternatively, the flag label may be applied manually by the operator. Aportion of the label around the barrel must be transparent to permitdosage markings of the syringe to be clearly visible.

As an alternative to the flag label printer/applicator 4, an on-demandlabel printer may be used which prints a patient-specific label ondemand. This arrangement would require the operator to manually applythe label to the syringe. After the label is printed, the operator willverify that the syringe was labeled correctly. This option is lessexpensive than the use of a semi-automatic flag label printer/applicator4 and will be offered as an option for substitution of same.

A fifth (optional) station is a medication container shake station forautomatically shaking the medicine container when necessary (see FIGS.16A and 16B). A shaking mechanism 820 integral to the filling station 5is described below. An alternative, remotely-positioned medicationcontainer shake station 6 is described more fully below with regard toFIG. 17 while a standalone or integral shaker module is described morefully below with regard to FIG. 16A.

For certain medications, such as those in the form of emulsions, liquidscontaining particulates or other non-homogeneous liquids, shaking isrequired prior to filling to render the mixture homogeneous. Within thiscategory of medications, certain medications need to be shaken at morefrequent intervals, and with a greater intensity, than other medicationsbased on the unique characteristics of each medication. Embodiments ofthe instant invention comprise an electronic medication databaseaccessible by the OSPS-S system. Information about any required shakingprotocols for each medication may be stored in the medication databasein association with the relevant medication(s). At the MedicationContainer Orientation and Login Station (FIG. 2 (I)) described herein,the method according to the present invention may involve the printingof a 2D barcode for each medication bottle which, when scanned at thefilling station 5, provides the OSPS-S system with the required shakingprotocol, if any, for the scanned medication. This will then prompt theOSPS-S system to cause the integral shake station 820 to shake themedication container before or after the filling operation with thefrequency, intensity and in the intervals as required for the givenmedication. This process advantageously prevents medication that isprone to settling or separating from doing so such that each syringecontains the proper composition of medication.

The sixth station is the syringe filling station 5 for filling thesyringes S. The operator positions the empty syringe S (step 840) at thesyringe filling station 5. A scanner 121 is resident at the syringefilling station 5 to automatically scan the machine readable label onthe bottom of the container 104 to again verify that the selected itemis correct. The hand-held scanner at the fill station 5 scans the labelattached to the syringe to verify that the appropriate syringe is beingused. The medicine container 104 and the syringe S are loaded into thefilling station 5 in various ways dependent upon the container/syringeinterface that is used. The fourteen container/syringe interfaces andassociated procedures for use are discussed in more detail above andbelow. The system automatically fills the syringe S with the medicine bycalibrated withdrawal of the plunger.

The seventh station is a visual inspection station 9 which comprisesoptical inspection to optically determine if the syringe is filledcorrectly. On this basis the System 100 accepts or rejects theweighed/inspected syringe.

FIG. 6A is a perspective view of an exemplary vision inspection station9 in which syringe fill volume is inspected by a CCD imager 330 thatoptically detects by image analysis if the syringe S plunger is at thecorrect location, the volume above the plunger and below the syringe tipis filled with product, and also checks for bubbles in the product.

With respect to FIGS. 6A and 6B, the illustrated embodiment of thevision inspection station 9 generally comprises a flat base 92 withvertical syringe-mounting plate 93 at one end, caddy-corner to avertical camera mounting plate 94. CCD imager 330 is mounted overhead ona camera-mounting bracket 95 extending upward from the camera mountingplate 94. A syringe holder 96 protrudes from the verticalsyringe-mounting plate 93 and suspends a syringe by its cap (two yokefingers under the cap). An optional syringe clamp 99 may be providedopposite the syringe holder 96 for clamping the syringe therein. In itssimplest form (shown), syringe clamp 99 is a spring-biased jaw thatclamps against holder 96 to secure the syringe. A backlight panel 97resides directly behind the syringe S (beneath syringe holder 96). Twoside-mounted lights 98 provide frontal illumination.

In operation, the vision inspection station 9 establishes and maintainsa “Reference Point” on each syringe which is consistent for all syringesdespite size, nozzle offset and other variables. In accordance with theinvention the reference point is selected to be just below the syringetip at its intersection with the top of the syringe body. Since thesyringe cap covers most of the syringe tip, and that tip volume is neverdispensed, the tip can be ignored from any vision reading taken. Thefilled and capped syringe S is preferably held stationary in thespring-loaded yoke fingers of syringe holder 96 by its cap, while thebacklit camera CCD 330 measures from a reference point to the seal ringof the syringe S plunger. Since the syringes are hung by their capswithin a common yoke they will all have the same zero reference point,despite varying sizes. The reading from the “Reference Point” downwardto the seal ring of the plunger comprises a numerical dimension for thespecific syringe S size relative to the prescribed dose (the sizeselected being the next larger size in excess of the dose). Once taken,the OSPS computer compares the reading to a predetermined valueassociated with that syringe size and every increment on the syringe.For example, if a 10 ml dose is prescribed the OSPS computer willrecommend a 20 ml syringe, in which case the distance from the“Reference Point” downward to the seal ring of the plunger (when fullyinserted) should be 32.75 mm or 1.289″. This way, given knowledge of theprescribed dose and the syringe size, the system can accuratelydetermine if the fill dose is correct. Otherwise it will be rejected.The accuracy of fill should be +−5% of target. In addition, the visioninspection may also include phase-contrast imaging to measure bubbles inthe syringe. Phase contrast imaging exploits differences in therefractive index of the contents to differentiate bubbles. Some bubblesare tolerable, but too many are not. The vision inspection may employphase-contrast imaging as a bubble check. This same process is used todetermine if the syringe is “short filled” based on differences inshading. Any voids or bubbles are interpreted as a mixed pixel count ineither light or dark depending on the opacity of the medication derivedfrom the OSPS computer database. If the syringe volume inspection device9 determines that the syringe S is filled to the correct volume with anacceptable amount of bubbles and no voids, it will be accepted. Anacceptable bubble/void percentage is +/−2%. Optionally, a digitalphotograph of the filled syringe may be taken and archived for track andtrace purposes. In a preferred embodiment, the color of the light may bechanged to give the greatest possible contrast over liquids of differentcolors and opacities. The lighting color may be determined by the visioninspection station 9 based on a scan of the 2D barcode on the syringe tobe inspected.

The illustrated embodiment reduces the footprint (size) of the visioninspection system 9 using a mirror to break up focal distance intoshorter lengths (here two, though additional mirrors may be used).Specifically, the overhead camera 330 view is reflected off a mirror 333mounted to wall 94, and is then focused on the syringe S beinginspected.

FIGS. 6C and 6D show two alternative articulating designs for thebacklight panel 97 which resides directly behind the syringe S (beneathsyringe-holder 96), both perspective sequential views, which facilitateeasier loading of the syringe S from behind. In FIG. 6C, thesyringe-holder 96 is mounted from a suspension or other non-obtrusivebracket to facilitate rearward access. The backlight panel 97 is mountedbehind the syringe-holder 96 on hinges or pivots 198 as shown, to allowthe backlight panel 97 to be opened or closed like a door. As shown inthe sequence, the operator places the filled, capped syringe S into thesyringe-holder 96 at (1), closes the backlight panel 97 at (2), the CCDimager 330 images the syringe S against the backlight panel 97 at (3),and the backlight panel 97 is reopened at (4) and the syringe S removed.

FIG. 6D shows a guillotine-style backlight panel 97 slidably mounted ona pair of spaced-apart vertical rails 195. Backlight panel 97 moves upand/or down within rails 195. As shown in the sequence, the operatorplaces the filled, capped syringe S into the syringe-holder 96 at (1),and closes the backlight panel 97 whereupon the CCD imager 330 imagesthe syringe S against the backlight panel 97 at (2). The backlight panel97 is then reopened and the syringe S removed.

As still another alternative, the inspection may be accomplished with acheck-weigh scale to weigh and/or inspect the filled syringe S to verifythe syringe is as labeled. In this case, the OSPS software calculatestarget weight based on the fill size in cc's and multiplies by thespecific gravity to derive weight. The specific gravity of eachmedication is stored in the OSPS database along with the percentage +/−%deviation that is acceptable for the actual fill weight. If the actualfill weight is in the target range, it is accepted. If not, it isrejected.

The OSPS software calculates the target weight based on the fill size incc's and multiplies by the specific gravity to derive weight. Thespecific gravity of each medication is stored in the OSPS database alongwith the percentage (+/−%) deviation that is acceptable for the actualfill weight. If the actual fill weight is in the target range, it isaccepted. If not, it is rejected.

An eighth station 8 is the semi-automatic syringe capping stationdescribed below in detail with regard to FIG. 10. The syringe cappingstation 8 facilitates accurate placement of syringe caps onto filledsyringes S.

The ninth station is a bag printing and sealing station 7 (see FIG. 2III). The bagging station 7 is a commercially available Hand LoadPrinter/Bagger for hand load labeling and bagging applications. It isnetworked to the local OSPS computer to automatically print the bag thatthe syringe S will be packaged in. The bag is printed with informationregarding the prescription such as the eventual contents of the syringe(medicine type, concentration, dosage, expiration, scheduledadministration, etc.) and its intended recipient (name, room number,etc.) along with a bar code identifying the same content. After printinga bag the system inspects the print on the bag to make sure that it iscorrect. If so, the operator is permitted to place the filled/cappedsyringe S in the bag, the system confirms that the syringe was placed inthe bag, and the bag is then sealed.

If all the steps are completed correctly the syringes are distributedfor administration to the patient.

One skilled in the art will recognize that certain steps may becompleted in various alternate sequences to achieve the same result, andfeatures may be modified or eliminated as a matter of design choice.

At initial MCLO Station 1 an operator prepares bulk medicine containersfor use at the automated syringe filling station 5. Preparation entailsapplying one of the above-described container/syringe interfaces. Again,each medicine container is pre-labeled with a unique identifying number,for example, in barcode format adhered to the bottom of the container.Preparation of the container 104 also includes scanning, verification,optional photographing, and recordation of container 104 labelinformation including content information (name, manufacturer, fullvolume, concentration, etc.), batch or production information, andexpiration information with its assigned container 104 in a medicationtrack and trace database. Various other parameters for each medicine canbe associated with each record in the database such as the maximum flowrate at which a certain medicine can be withdrawn from its storagecontainer (i.e. to prevent cavitation/inaccurate fills), the storagetemperature (ambient or refrigerated), the required frequency ofshaking/agitation of each medicine to keep any particulate matterproperly suspended/distributed (e.g. between each syringe fill dispensecycle or only at the start of a series of syringe fill dispense cycles).

Each barcode (or possibly RFID tag or other label) preferably referencesthe following information:

-   -   Batch number    -   Expiry date    -   Storage instructions    -   Product name    -   Strength    -   Name of the active ingredient(s)    -   Dose form    -   Warning statements    -   FDA number    -   Des product need to be shaken before use? If so, how often?    -   Does product need to be refrigerated before use? If so, temp?    -   Does product need to be protected from light?    -   Volume of original bulk medication container?

The information available from the pharmaceutical manufacturer's barcodeon the medication container varies from manufacturer to manufacturer.The operator is prompted to enter any missing data directly into thecomputer data entry terminal 96 at MCLO Station 1. The information fromthe pharmaceutical manufacturer's barcode label plus the variableinformation is stored in the medication container database which islinked to the medication container by the barcode label on the base ofthe container, which includes the container identifying number assignedto the container 104 in the medication track and trace database. It isalso important that each container 104 is marked in both human andmachine readable forms (i.e. text, barcode or RFID tag) as to the typeand concentration of the medication it contains along with various otherinformation, to enable visual inspection.

The containers/bottles 104 are typically manufacturer-supplied althoughcustom containers/bottles may be used for purposes of the presentsystem. If the storage containers or bottles 104 are provided by themanufacturer, 20 mm, 24 mm, and 28 mm neck diameters are typical. Thebulk containers may be provided in a specified, standardized format bythe manufacturer, or the medicines may be refilled into standardizedcontainers onsite.

With regard to filling station 5 in FIG. 2, the oral syringe may beentirely evacuated such that its plunger is advanced all the way intoits barrel or the oral syringe may have a calibrated amount of a gas(such as air) in front of the plunger in the barrel. The syringe plungermay be withdrawn to draw the fluid into the barrel. Where a gas ispresent in the syringe, the plunger may be first advanced so as to forcethe gas into the container 104. The plunger is then withdrawn to drawthe fluid into the syringe. Introduction of the gas into the container104 slightly pressurizes the container initially and prevents thedevelopment of negative pressure within the container which wouldinhibit fluid flow. When the syringe is filled to the proper volume itis withdrawn.

Referring back to FIG. 2, the operator returns the prepared medicinecontainer 104 with its container/syringe interface 210, 212, 214, 216,220, 221, 226, 223 and 224 in the medicine Storage Facility 2 where itremains until called for. The system software monitors the contents ofthe medicine Storage facility 2 in terms of both identity of theprepared medicines available to be dispensed and the quantity of eachmedicine. The content of the Storage facility 2 is continually updatedas the medicine is dispensed and the system is able to predict based oncurrent pending prescription and historical dispensing information whenthe current available container of any given medication will be empty soas to advise the operator to prepare a replacement quantity of suchmedicine prior to emptying the existing container. Medicines exceedingtheir expiry dates are also identified by the system to be discarded bythe operator.

After retrieving the syringe from syringe store 3 (see FIG. 2 III) ofempty syringes S to be filled as described above, the operator insertsthe syringe into a station that includes a syringe color/size inspectiondevice 11 and a syringe label printer/applicator 4.

FIG. 15A is a perspective view of an embodiment of the syringesize/color station 11A which verifies that the correct syringe size (0.5ml, 1 ml, 3 ml, 5 ml, 10 ml, 20 ml, 35 ml, and 60 ml)) has been selectedby the operator. One skilled in the art should understand that syringesize/color inspection station 11A may be placed anywhere but is bestplaced proximate the filling station 5. The illustrated syringesize/color inspection station 11A essentially comprises a set ofautomatic electronic calipers connected to the OSPS Computer. Morespecifically, a support surface 1101 is formed with a pair of alignedslots 1103, 1104. A stationary cradle comprises a pair of spaced-apartyokes 1102 a, 1102 b fixedly mounted on the support surface 1101 onopposite sides of the slots 1103, 1104 for supporting the syringe S in ahorizontal position. A pair of articulating caliper fingers 1105protrude upward through the slots 1103, 1104 to embrace the syringe S onboth sides. Caliper fingers 1105 are driven by an underlying caliperdrive mechanism connected to the OSPS Computer which moves fingers 1105into contact with the syringe S after the shuttle 5 s has deposited thesyringe S onto the yokes 1102 a, 1102 b. The caliper fingers 1105 riseto a height higher than the center of the largest syringe size, and inoperation the fingers 1105 close around the body of the syringe S untila force is sensed (indicating contact with the syringe). At this point ameasurement of the syringe body is taken (the distance between fingers1105 is calculated) to verify that the correct syringe S has beenselected. Oral syringes are often color coded in translucent colors forease of identification. For example, oral syringes may be a highlyvisible amber color to distinguish its contents as an orallyadministered medication. To verify color, a color inspection camera 1107is also connected to the OSPS computer and may be mounted in either ofyokes 1102 a, 1102 b to image the color of the syringe S. A 3-CMOSimager is preferred for this application to capture RGB pixel data,which is compared by OSPS Computer to a color lookup table or subjectedto another color-matching algorithm to verify the proper syringe color.If size and/or color are correct, labeling and/or further processing ofthe syringe S will take place.

FIG. 15B is a perspective view of an alternate embodiment of a syringesize/color station 11B which verifies that the correct syringe has beenselected. Embodiment 11B comprises a parallel pneumatic gripper 1201fixedly mounted at a downward incline within a supporting structure herecomprising opposing vertical plates 1210, 1212 connected by a cross-bar1214. There are a variety of commercially-available pneumatic grippersavailable in parallel, angular, radial and concentric versions, and inthis instance a parallel version is used, such as a Rexroth™ GSPprecision parallel pneumatic gripper. Opposing syringe gripper jaws 1220are attached to the existing gripper 1210 arms, each jaw 1220 comprisinga downward extension to a horizontally-disposed finger. The opposedhorizontal fingers 1220 are formed with inwardly-disposed verticalgrooves to provide a proper grip on the syringe barrel, while holding itvertically. A linear variable differential transformer (LVDT) 1225 (alsocalled a differential transformer) is mounted in plate 1210, and itssensing piston is threaded into a collar 1227 secured to the opposingjaw 1220 for measuring linear displacement (position). The LVDT 1225 isconnected to the OSPS Computer and measures the distance traveled by thejaw 1220 as it closes around a syringe S. The LVDT 1225 takes monitorsan input voltage differential from a starting position to a finalposition after gripping the syringe S, and calculates syringe size fromdistance traveled by the jaw 1220. As above, to verify color a colorinspection camera 1107 may be mounted in either of plates 1210, 1212 toimage the color of the syringe S and thereby ensure that size and colorare correct, such that labeling and/or further processing of the syringeS may take place. One skilled in the art should understand that thesyringe measurement system 11B may be integrated as part of the syringefilling station 5 (see FIG. 2 III) rather than as a standalone stationas shown in FIG. 15B, thereby consolidating the size/color inspectionfunction with the filling operation.

The labeler 4 is in communication with the central controller and printsself-adhesive labels bearing information regarding the prescription suchas the eventual contents of the syringe (medicine, dosage, scheduledadministration, etc.) and its intended recipient (name, room number,etc.) along with a bar code identifying a central record of thisinformation. The label is printed, scanned (inspected) and, if approved,applied to the syringe using known application methods. In one suchmethod the label is supported by the hinged arms of the applicator byvacuum pressure while the applicator advances to envelop the syringebarrel with the hinged arms coming together to join the label as a flagto the barrel. A portion of the label around the barrel must betransparent to permit dosage markings of the syringe to be clearlyvisible. Alternatively, an on-demand label printer, for manualapplication of the label to the syringe, may be used in place of labeler4.

FIG. 7A is an enlarged perspective view of a semi-automated syringe fillstation 5 for filling the syringes S. Prior to inserting the syringeinto the syringe filling station 5, the operator will have selected fromthe Storage facility 2 the appropriate, prepared container 104 with avalved PIBA (see FIG. 5) from which to dispense the proper medicine intothe syringe S. The operator first inverts and then inserts the preparedcontainer 104 into yoke 82C (see FIG. 7C III). The syringe S is thenmanually loaded by the operator into the syringe filling station 5,preferably with the plunger partially withdrawn from the barrel. Thesyringe S/plunger combination is inserted into the medicine container.Several support fixture/yoke variations are envisioned.

As seen in FIG. 8, each arm terminates in a pair of fork shaped fingers120 that form a horizontally oriented “V” shaped opening to engage thesyringe barrel and plunger cross sections regardless of the size ofthese elements. Each arm is independently servo controlled and slideablein both an up-down direction and a horizontal forward-back direction tofacilitate engagement with and operation of the syringe and plunger. Theupper and middle arms 110, 111 grip above and below the syringe barrelflange, while the lower arm 112 grips the plunger flange. The local OSPScomputer calculates the distance to move the lower arm 112, plungerlifting arm 128 and plunger flange to extract the appropriate dose ofmedicine based on the prescribed dose volume V and known radius ordiameter of the syringe S size retrieved. The linear travel distance Hequals V/nr², where the radius r is stored in the database. The lineartravel distance H constitutes the distance that the lower arm 112 needsto travel to pull the correct amount of medicine into the syringe S. Thelocal OSPS computer then controls the movement of fill arms 110, 111,112 and plunger lifting arm 128 in accordance with the calculateddistance H, and may also account for other variables such as medicineviscosity, volume of fill, etc. to optimize either the linear traveldistance H or the filling force exerted or filling time taken along thatdistance.

With reference to FIG. 9, a preferred embodiment of the presentinvention provides the upper, middle and lower arms 110, 111 and 112,respectively, in a single stacked configuration each having ahorizontally fixed base member 129 riding on a pair of ball slides 122on a set of guide rails 123 vertically oriented with the housing 895 (ofFIG. 7A). Vertical movement of each base member 129 on the guide rails123 is controlled by a linear servo 124 situated below and extendinginto the housing 895. Each arm 110, 111, 112 is also provided with ahorizontal reaching element 127 slideably mounted horizontally to eachbase member 129 so as to ride up or down the guide rails 123 with thebase member 129 while being extendable or retractable in the horizontalto engage the syringe S. Horizontal extension and retraction of thereaching members 127 is controlled by a horizontally oriented linearservo 125 fixedly mounted to each base member 129 and engaged to theproximate reaching element 127, each which is itself mounted via ahorizontally oriented ball slide assembly 126 affixed to the base member129. The forked fingers 120 are horizontally disposed at the distal endsof the reaching elements 127. In this way the horizontal and verticalmotion of each arm 110, 111, 112 is individually controllable in twodimensions.

Referring back to FIG. 7A, in addition to the upper, middle and lowerarms 110, 111, 112, a plunger lifting arm 128 extends upward from belowto depress the plunger of the syringe S into the barrel as will bedescribed. The plunger lifting arm 128 is controlled by a linear servoand is vertically oriented. In certain embodiments the lower arm 112 mayserve both the plunger pull-down (withdraw) and plunger lift (depress)operations.

In an alternate embodiment, as shown in FIGS. 26 and 27, instead ofhorizontally extending syringe gripping arms with two-dimensionalhorizontal and vertical motion of each arm 110, 111, 112, verticallyextending syringe gripping arms are implemented with vertical androtational motion of each arm 110, 111, 112. This is made possible byreplacing the laterally-extended fork-shaped fingers each with standard“V” shaped openings with one or more right-angle plates each having atransverse curvilinear notch or “curvilinear jaw.” This way, eachsyringe gripping arm 110, 111 and 112 terminates with at least onehorizontally-oriented curvilinear jaw, wherein the notch forms anoverall curved shape along the horizontal plane of the gripping arms110, 111 and 112 which lessens in width towards its closed end. Theadvantage of this configuration is that the syringe gripping arms 110,111, 112 extend vertically from the horizontal base member of thefilling station and may enter the filling station through fluid-sealedbushings, whereas the above-described two-dimensional embodimentrequires elongate slots to permit vertical movement of the arms, butwhich are difficult to seal to prevent liquid medication and othermaterials from infiltrating into the interior of the filling station.Where the filling station is expected to operate in a clean-roomenvironment, the ability to environmentally seal the external fillingarea is an absolute requirement, and the use of vertical/rotationalsyringe gripping arms 110, 111, 112 rotating within sealed rotarybushings makes this possible. Additionally, in this embodiment, thesealed interface between the vertical rotating mounting elements forarms 110, 111, 112 and 128 and the base plate of the filling stationprevents any liquids or other materials spilled during the fillingprocess or otherwise from leaking into the interior of the fillingstation. In this embodiment, arms 110, 111 and 112 may be mountedthrough a horizontal base member of the filling station, extendingthrough rotary shaft seals, and attached to linear and rotational servomotors mounted underneath the filling station base that control themotion of the arms 110, 111, 112 (as well as plunger lifting arm 128) aswill be described. The servo motors thus control vertical position andaxial rotation of the vertical mounting elements and therefore the arms110, 111, 112 and 128 mounted thereon, with plunger lifting armrequiring only the capacity to raise and lower vertically, and not torotate. Thus, as vertical mounting elements and arms 110, 111 and 112rotate, they close on the various portions of syringe S corresponding totheir vertical orientation. Arms 110, 111 and 112 may rotate as far aspossible to grasp syringe S until the curvilinear gap between thefingers matches the width of the portion of syringe S upon which itcloses; thus, arms 110, 111 and 112 will rotate under control of theservo motors until syringe S is snugly positioned within the gap betweenthe fingers. In addition, upper and middle arms 110 and 111 may rest onthe same vertical mounting element spaced vertically from one another,with a clamping cylinder incorporated there between to control theirrelative vertical orientation. Clamping cylinder may pull upper arm 110down on top of middle arm 111 to sandwich the syringe hilt or flangebetween them as described. Advantageously, the use of a low costclamping cylinder eliminates a more costly servo motor to independentlyoperate arm 110 and/or 111. In all other respects, arms 110, 111, 112and 128 may perform the same functions as described herein.

Prior to filling, the scanner 121 at the syringe filling station 5 readsthe machine readable label on the bottom surface of the container 104 toagain verify that the selected container contains the correct medicine.

Once verified to be the correct, the upper arm 110 lowers to contact theupper surface of the syringe S finger flange, and the middle arm 111raises to contact the lower surface of the syringe S finger flange.Initially, plunger lifting arm 128 pushes the syringe piston all the wayup and the lower arm 112 lowers to clamp the syringe piston downwardagainst the plunger lifting arm 128. Priming of the syringe S takesplace as lower arm 112 and plunger lifting arm 128 move up and down inconcert with each other to perform the syringe priming sequence. Afterpriming is complete and with the syringe piston fully retracted, thesyringe can be filled.

During fill operations the upper, middle and lower arms 110, 111 and 112are initially in a horizontally retracted state. The lower arm 112engages the plunger above the plunger flange in a similar manner whilethe lift arm 128 extends upward to engage the distal end of the plunger.The lower and lift arms 112, 128 are brought together to engage trap theplunger flange between them, and the syringe S is entirely evacuated byfully depressing the plunger within the barrel. If the syringe S isentirely evacuated (i.e. the plunger is fully depressed within thebarrel), the lower arm 112 is initially dropped, withdrawing the plungerfrom the barrel and drawing the medicine into the syringe. As noted, incertain embodiments the syringe may have a predetermined amount of airin the barrel to pre-pressurize the container 104. In such a situationthe position of the plunger (and hence the volume of air in the barrelto be injected into the container) is determined by the system based onknown parameters of the medicine, the container volume and its currentfill level, and the plunger is positioned accordingly prior to insertioninto the container/syringe interface by relative movement of the upper,middle, lower and lifting arms 110, 111, 112 and 128. Upon insertion ofthe tip in the container/syringe interface the plunger is first fullydepressed by the lift arm 128 to pressurize the container andsubsequently withdrawn by the lower arm 112 at a predetermined rate tofill the syringe S with desired amount of medicine without cavitation.

When the syringe is filled to the desired level, the arms 110, 111, 112and 128 are lowered in unison and the syringe S is withdrawn from thecontainer/syringe interface 210, 212, 214, 216 and where an elastomericinsert 225 is present it returns to it closed/sealed position. Ifdesired, the syringe plunger may be further withdrawn from the barrelslightly by relative movement of the lower arm 112 as the nozzle iswithdrawn to draw in any medicine left in the elastomeric insert 225 soas to avoid drippage.

With reference to FIGS. 40-43, where a push-pull cap 224 is used as thesyringe-medication container interface to enable the medicationcontainer to interface with a Luer lock oral syringe, syringe fillingstation 5 additionally comprises a grooved block 400 for actuating slidedisc 91 to open and close push-pull cap 224 between each syringe fill.As shown in FIG. 43 (at A), grooved block 400 comprises a horizontalblock having a cutout through the entire height thereof to accommodatethe exterior diameter of push-pull cap 224 above and below slide disc91. At a height-wise midpoint of the inner wall of the cutout is agroove corresponding to the outer diameter of slide disc 91 such thatslide disc may be captured within the groove when the medicationcontainer is properly positioned in yoke 82. Grooved block 400 ispositioned a given distance below yoke 82 such that it captures slidedisc 91 within its groove when push-pull cap 224 is in a closed position(with slide disc 91 raised and tab 86 in upper groove 87 a; see FIG. 29at B) and is movable vertically relative to stationary yoke 82.

In a first embodiment, shown in FIG. 41, grooved block 400 isoperatively connected to a horizontal air cylinder 401 via two cams 404comprising cam slots 402. Air cylinder 401 is in turn connected to OSPSsoftware for controlling the operation of air cylinder 401 based on oneor more programmed syringe filling sequences. When air cylinder 401 isretracted, cams 404 move inward towards air cylinder 401 and away fromthe syringe and medication container. Two cam followers 405 each have ahorizontal arm, a portion of which is disposed in one of the two camslots, and a vertical arm connected to the horizontal arm and extendingdownward through yoke 82 to connect to grooved block 400. Cam followers405 are held stationary within the horizontal plane but movable withinthe vertical plane, such that when cams 404 move inward, cam followers405 are pushed downward following the downward incline of the cam slots402 in the direction opposite that in which cams 404 are moving. Bytheir attachment to grooved block 400, cam followers 405 in turn pushgrooved block 400 downward which forces the slide disc 91 held withingrooved block 400 downward, opening push-pull cap 224. Likewise, whenair cylinder 401 is extended, cams 404 move outward away from aircylinder 401, cam followers 405 are pulled upward following the upwardincline of the cam slots 402, grooved block 400 is pulled upward andslide disc 91 is pulled upward, closing push-pull cap 224. Syringegripping arms 78 are also mounted to grooved block 400 such that thesyringe body is pulled upward or downward in the same magnitude as slidedisc 91 and nozzle 90 of push-pull cap 224 such that a connectionbetween the syringe S and nozzle 90 is constantly maintained untilpush-pull cap 224 is closed and the syringe S is removed from thefiller. For filling operations not involving a push-pull cap 224,grooved block can be articulated out of the way and air cylinder 401will hold syringe gripping fingers 78 in a stationary position relativeto yoke 82.

In a second embodiment, shown in FIG. 42, the operation of grooved block400 and its interface with slide disc 91 and syringe gripping fingers 78is the same as described above. However, horizontal air cylinder 401 isreplaced by vertical air cylinder 403 which moves grooved block 400 in avertical direction directly without the need to utilize cam slots 402.

To enable the conversion between the use of tapered tip syringes (FIG.38) and Luer lock syringes (FIG. 39) as is expected in the future forsafety reasons, the entire system described herein may be modular toallow replacement of those modules designed specifically for tapered tipsyringes as the Luer lock syringe rollout takes place.

FIG. 16A illustrates an shaker mechanism 820, which may be eitherintegral to filling station 5 or a standalone unit, in which asingle-speed motor 823 operates through an electronic clutch 827 torotate cam wheel 824. In a preferred embodiment, filling station 5comprises a base module containing syringe gripping fingers and a topmodule for supporting the medication container in an inverted positionfor filling the syringe. The top module may be shaker mechanism 820, ormay be a module comprising medication container yoke 82A, 82B and/orself-centering jaws 82C and medication container platform 79 without anyintegral shaking mechanism, such as when a separate shaking mechanism 6is used. Preferably, either of these top modules may be interchangeablebased on design preference to allow for, i.e., an upgrade of the systemfrom comprising an independent shaker mechanism 6 to integral shakingmechanism 820 or to allow the system to be adaptable to different needs.The top module and base module may be connected by a series of screws orany other non-permanent connection means known in the art.

For shaking mechanism 820, an eccentric pin 829 protruding from camwheel 824 slidably engages a slotted block 830 as shown, and block 830directly engages plate 821. When the motor 823 is activated itreciprocates plate 821, again shaking it and mixing the contents ofmedicine container 104 held therein.

FIG. 16B is a composite operational diagram illustrating the operationof the integral shaking mechanism 820 of FIG. 16A external of thesyringe filling station 5. The plate 821 which supports the medicinecontainer platform and syringe yoke is mounted on vertical slides 831. Aslotted driven block 832 mounted on the plate 821 is engaged byeccentric pin 829. As the pin 829 rotates within the slot of block 832the block 832 oscillates up and down. A single position clutch ismounted to the motor so that the slotted driven block as well as theentire platform stops at the same downward position all the time. Theinsets at top illustrate eccentric pin 829 engaging slotted driven plate832 at top dead center (left), 90 degrees rotation, and bottom deadcenter.

FIG. 17 is a perspective view of an alternative remote medicationcontainer shake station 6 (i.e. not an integral part of the fillingstation 5 as seen in FIG. 2) for shaking the medicine container whenrequired. The shake station 6 comprises a motor 62 with an offset trough64 coupled to the rotary shaft 63. The trough 64 is an elongate archedplatform for seating and centering medicine containers of various sizes.An upright post 65 abuts the base of the medicine container andself-centers it, allowing tightening of restraining straps 66. Thestraps 66 secure the medicine container along an oblique offset axisrelative to that of the shaft 63. This particular configuration makesloading of the medicine container on the trough 64 very easy as seen inFIG. 17. When the motor 62 is activated the oblique rotation of themedicine container causes a centrifugal force that keeps the containeragainst the stop post 64. Constrained by the bands 66 and post 65 themedicine container is effectively and efficiently shaken.

The (optional) semi-automated capping station 8 (see FIG. 2) facilitatessyringe cap placement on the open tip of the filled syringe S, fed froman inclined capping chute 149 (see FIG. 10). Referring back, FIG. 10 isan enlarged perspective view of the semi-automated capping station 8with feeder bowl 147 and inclined capping chute 149. Feeder bowl 147 maybe a centrifugal or vibratory bowl feeder as known in the art, sized forsorting and feeding syringe S caps single-file down inclined chute 149.A transparent plastic chute cover 145 may be provided overtop chute 149to prevent access to all but the leading syringe S cap. It is rathercommon for pharmacy technicians to improperly cap filled syringes priorto administration, and this leads to leaking, contamination and otherproblems. A mechanism is herein provided to prevent this. When theleading syringe caps reach the bottom of chute 149 they come to bearagainst a cylinder rod 146 in a position directly overhead an electronicpressure transducer 148. Pressure transducer 148 is in communicationwith the OSPS central controller and registers the pressure of thesyringe S nozzle pressing against transducer 148. A threshold pressureindicator LED 144 is mounted proximate transducer 148. To cap a syringeS the operator merely presses it down onto the leading cap until anacceptable threshold pressure is attained, and this is signaled by anLED indicator 144. At this point the cylinder rod 146 retracts allowingthe operator to pull the capped syringe S out and free. The OSPS centralcontroller preferably logs this in its track and trace database toprovide an audit trail. This mechanism avoids any issues with improperlycapped syringes.

During batch operation a series of syringes S to be filled with the samemedicine may be queued and loaded in sequence by the operator forfilling. When no more syringes are to be filled with the particularmedicine, the local container 104 is returned to the medicine Storagefacility 2 by the operator, who may retrieve another medicine andreplace it in the syringe filling station 5 for the next medicine to bedispensed.

In a preferred embodiment, a 2D barcode on the syringe, medicationcontainer or cap may be scanned at each station described herein, andred/green lights or another visual or audible alert may indicate to theoperator and/or to the software that a required protocol has not beenfollowed for a given syringe, medication, or the like. For instance, ared light may be used to indicate, when a medication container isscanned at filling station 5, that the medication has expired, or toindicate, at the visual inspection station 9, that syringe S has notbeen filled to the proper fill volume as required for a givenprescription. Scanning a 2D barcode at each station described hereinwould also permit the pharmacist or other operator to process medicationor syringe/cap/container recalls more promptly and prevent any recalleditems or medication from being provided to a patient. Recall informationmay be entered directly into the OSPS system when received by thehospital or pharmacy and the software may check every scanned itemagainst the database of recalled medications and/or devices.

The 2D barcode described herein is preferably generated for syringe S atthe syringe labeling station, and for the medication container at theMedication Container Orientation and Login Station (FIG. 2 (I)). Thus,in a preferred embodiment, the 2D barcode on the medication container isscanned at the Medication Container Orientation and Login Station (afterit is generated) and the filling station 5, and the 2D barcode on thesyringe S is scanned at the syringe labeling station (after it isgenerated), the filling station 5, syringe capping station 8, filledsyringe inspection station 9, and bagging station 7.

Referring back to FIG. 2, after retrieval from the syringe fillingstation 5 and capping at syringe capping station 8, the operator placesthe syringe on inspection system 9 to cross check the weight and/orvolume of the filled syringe against the expected weight/volume. Thetare weight check is based on the known weight of the empty syringe andthe volume of the prescribed medicine. The vision inspection entails anoptical inspection (described above) based on the location of thesyringe S plunger, the volume above the plunger and below the syringetip, and bubble check. If the inspection station 9 determines that thesyringe is filled to the correct volume and/or weight with an acceptableamount of bubbles, it will be accepted. Otherwise it will be rejected.

The labeled, filled and capped syringe is then bagged at bagger 7 fordistribution to the patient, the bag itself being labeled in a similarmanner as to the syringe. Bagger 7 may be any suitablecommercially-available bagger with a network-capable bag printer, bagstorage/dispenser, and heat seal assembly. A variety of automatic“tabletop bagger/printers” are available for this purpose.

With reference to FIGS. 11 and 12, a control system architecture for thesystem 100 is disclosed in which a main controller 300 is provided incommunication with a series of sub-controllers for one or more stationsteps via a communications backbone 310, in the depicted case, viaEthernet and local digital inputs and outputs. The main controller 300is preferably a microprocessor based microcontroller or PC containing aprocessor core, memory, and programmable input/output peripherals. Thecontroller contains a system safety controller, logic controller, toplevel motion controller and human-machine interface for interaction witha system operator. The main controller 300 further incorporates adatabase read/write module for interaction with a local or remotecustomer (patient) records database and local event database formanaging downstream component operation. An order listener/parser moduleis provided for receiving orders from an external pharmacy/prescriptionentry and management system maintained by the institution. The parsercan be custom formatted to discern and populate order information basedon a user specified data stream and structure.

Sub-controllers are provided for all downstream machine sections such asSyringe Storage 320, Inspector/Labeler/verifier 330, and MedicineLibrary 350. The sub-controllers are each provided with a localinput/output system and local motion controller integrated with the maincontroller 300 via the communications backbone 310. The main controllerorchestrates the integration and operation of the downstream machineelements as described above and controls the overall operational mode ofthe system 100.

The local OSPS Computer may incorporate fill weight/volume adjustmentsoftware. Specifically, the vision inspection station 9 (FIG. 2) isnetworked to the Local OSPS Computer and may provide weight or volumefeedback to automatically adjust the amount of liquid transferred intothe oral syringe at servo-operated syringe filling station 5. Thesoftware determines if a syringe has too much or too little medicine init. Any out-of-spec syringe will be rejected and the system willautomatically queue a replacement utilizing information from thepreviously-rejected syringe.

FIG. 13 is a perspective view of an exemplary capping/decapping station93, which comprises an elevated platform support surface 952 forstabilizing the medicine container. An optional container clamp (notshown) may be mounted on the support surface 952 for centering andconstraining the medicine container. The container clamp may comprise apair of opposing V-shaped clamps. An operator presses a “clamp” buttonand the opposing V-shaped clamps close around the container bottle. TheV-shaped clamps may be mounted on low-friction slides so that any sizebottle can be slid toward the center of the chuck. Although the clampsare mounted on low friction slides, they remain stationary to rotation.An articulating spindle assembly extends upward from a base 953 mountedon the support surface 952, the spindle assembly including a verticalpiston 954 extendable/retractable from base 953 and a horizontal mast955 extending from piston 954. The mast 955 contains a motor whichdrives a vertical spindle 959. A manual lowering arm 956 is geared tothe piston 954 for piston extension/retraction from base 953, therebyallowing an operator to raise or lower spindle 959 manually. A pressuresensor 957 is mounted to the spindle 959 (or internal to the mast 955for sensing the downward pressure. A chuck 958 is mounted at the lowerend of the spindle 959. As seen in the inset (at left), the chuck 958 ispreferably formed with a hard outer shell (e.g., stainless steel) and amolded plastic core placed inside, the core defined by a conicalinterior surface with an elastomeric inner lining. An elastomer such aspolyurethane or equivalent resin can be poured around the interior ofthe core to form the elastomeric lining. A lateral slot enters theinterior of the chuck 958. This chuck 958 is designed to fit all capsranging from 18 mm to 38 mm in diameter. Due to its conical interior andelastomeric inner lining, downward pressure onto the container capcauses a non-slip, gripping action. The slot accommodates certaincontainer caps which have a tethered closure feature. The tether is freeto protrude and will not cause interference between the chuck 958 andcap. This capping/decapping station 93 enables the medicine caps to beloosened from their containers mechanically without the need for anoperator to exert strong hand pressure. The system is capable ofloosening caps as well as applying torque to seat them. In operation,the medicine container is placed on the support surface 952, and theoperator centers the container either with the optional holding clamp orby hand, and if to cap a pre-labeled container/syringe interface isplaced on the container. Upon moving the manual lowering arm 956forward, the piston 954 extends from base 953, thereby a loweringspindle 959. The chuck 958 descends into contact with thecontainer/syringe interface to tighten it, or into contact with themanufacturer cap if decapping is desired. Once the chuck 958 descendsonto the cap and downward force is applied the pressure sensor 957begins to compress and in doing so, signals the motor to start. Thisavoids inadvertent rotation of the elastomeric chuck 958 in advance ofcontacting the cap which may cause abrasion and emit particles of theelastomer in the vicinity of the work area. The scanner 95A may bemounted beneath the platform support 952 to read the medicinecontainer's 2D barcode from beneath. Preferably, the scanner 95A issynchronized via the OSPS computer such that the first time it reads aparticular barcode the spindle 959/motor turn in the counter-clockwise(cap removal) direction. Conversely, the second time scanner 95A readsthat particular barcode the spindle 959/motor turn in the clockwise (captightening) direction. The assembled medicine container andcontainer/syringe interface can be slid out and removed.

FIG. 14 is a perspective view of the label photographing station 98resident at the Medication Container Orientation and Log-In Station. Thelabel photographing station 98 is employed for the purpose ofphotographing the entire medicine container's label for archivalpurposes (to retain a record of the medication used to fill a specificprescription). In some cases, the barcode scan from scanner 95A alonewill be insufficient to identify details such as medicine concentration,expiration, handling and other precautions relative to the medication.The label photographing station 98 comprises a circular table 984rotatably seated atop a support surface 982. A camera 988 is orienteddirectly toward a focal point centrally atop the table 984, and a pairof opposing sensors 986 a. 986 b is indirectly aimed from the sidestoward that same focal point. The camera 988 and sensors 986 a, 986 bare all mounted on a common undercarriage via struts that pass throughtracks in the table 984. This allows the camera 988 and sensors 986 a,986 b to translate in unison along the tracks in the table 984. Theundercarriage is servo-driven (or otherwise adapted for controlledtranslation) under control on the OSPS Computer, in accordance withfeedback from sensors 986 a, 986 b. The medicine container may bemanually placed anywhere atop the table 984, and the OSPS Computer willdrive the undercarriage until the sensors 986 a, 986 b align with thesurface of the medicine container. The sensors 986 a, 986 b track thesurface of the container and travel with that focal surface, along withthe camera 988. This positions the camera 988 at exactly the properfocal distance regardless of container position, and maintains theoptimum focal distance from label to camera 988 despite a variety ofsizes and shapes of medicine containers.

Process and System Configuration Variations Specific toContainer/Syringe Interfaces

Filling a Syringe Using a Standard Commercially Available “Baxa” Cap 214(See FIG. 5)

The standard commercially available Baxa™ cap 214 comprises a femalethreaded cap to fit over medication containers and is available in sizesto accommodate most medication containers. Baxa™ cap 214 enables an oralsyringe to enter its center hole and withdraw an amount of liquid fromthe medication container while the medication container is positionedupside down. For the syringe to be removed from the medication, bothsyringe and medication container must be up-righted. Once up-righted,the syringe S can be removed from the up-righted medication bottle withno leakage. If the medication bottle requires shaking at any given time,it can be done manually or in a separate shaker (FIG. 17) by closing thetethered cap and fastening the bottle into the shaker tray. The sequenceof operation is as follows:

-   -   a. Remove original cap (FIG. 18A).    -   b. The Baxa™_cap 214 is applied onto the neck of the container        (FIG. 18B).    -   c. The syringe S is inserted into the Baxa™ cap 214. (FIG. 18C).    -   d. The medication container and the syringe S combination are        rotated up-side-down. (FIG. 18D).    -   e. Both the medication container and the inserted syringe S are        then inverted and placed into the yoke 82A (FIG. 18E) of the        filling station 5 (see FIG. 7A).    -   f. The Syringe is clamped by the filler finger grippers 78 and a        platform 79 (FIG. 18F) lowers to the bottom of the over turned        medication bottle and applies downward pressure to the bottle as        it is supported by the yoke 82 (see FIG. 7D).    -   g. Now the syringe gripping arms 110, 111 and 112 engage the        syringe S plunger, prime and pull the plunger to the exact fill        dose (see FIG. 7A).    -   h. Remove medication container and the syringe S combination and        extract syringe S.

Filling an Oral Syringe Using an OEM-Baxa™ Cap with Self Sealing Valve216 (See FIG. 5)

As described above the standard Baxa™ cap is modified to incorporate aself-sealing valve 216 which enables an oral syringe S to enter itscenter hole while the medication container is positioned upside downwithout leaking. The Baxa™ Cap with Self Sealing Valve 216 also allowsfor syringes to be removed after filling without removing the medicationcontainer from the filing station 5 (see FIG. 2 III) and repeat thefilling of subsequent syringes S when a quantity of syringes are to befilled with the same medication. In the event of a scheduled shakingrequirement, after a specified amount of time, the system can shake themedication without removing it from the filling station (see FIG. 16A).Frequency and strokes per minute are pre-programmed into the system. Thesequence of operation is as follows:

-   -   a. Remove original cap (FIG. 19A).    -   b. Baxa™ Cap with Self Sealing Valve 216 is tightened onto the        neck of the container (FIG. 19B).    -   c. Medication container is turned upside down (see FIG. 19C).        The neck of the container is placed into a slotted yoke 82B or        the self-centering spring loaded jaws 82C (FIG. 7B). Since the        neck of the container is held on center by the slotted yoke 82B,        or the self-centering spring loaded jaws 82C the opening to the        Baxa Cap with Self Sealing valve 216 will be properly aligned        with the syringe S and the mechanism for filling the syringe S        by pulling the syringe plunger downward. (see FIG. 19C).    -   d. The medication container platform 79 is lowered to securely        hold the medication container in place onto either the Yoke 82A        (see FIG. 19C).    -   e. If the medication container needs to be shaken, it is shaken        at the programmed speed, duration and frequency (see FIG. 16A).    -   f. The syringe S tip is inserted up, into the Baxa Cap with Self        Sealing Valve opening 216.    -   g. The syringe S is filled by the syringe gripping arms 110, 111        and 112 which engage the syringe S plunger, prime and pull the        plunger to the exact fill dose (see FIG. 19D).    -   h. The syringe is unclamped by the filler finger grippers 78 and        the syringe is removed from the Medication container (FIG. 19D).    -   i. If additional syringes S need to be filled with the same        medication, the process is repeated.    -   j. When all syringes have been filled with the medication, the        platform 79 rises and the medication bottle is removed.    -   k. This process continues until all syringes for that        prescription production run have been filled.

Filling a Syringe Using a PIBA (No Valve) 210 (See FIG. 5)

If a medication container with valveless PIBA 210 requires shaking, thismust be done either manually or with the optional free standing shaker(FIG. 17). This must be repeated every time shaking is requiredregardless of whether the same medication is being filled into multiplesyringes. The original cap must be placed over the Medication bottle andits press-in insert, during storage, to ensure cleanliness. The sequenceof operation is as follows:

-   -   a. Remove medicine bottle cap (FIG. 20A).    -   b. The valveless PIBA 210 is inserted into the neck of the        container (FIG. 20B).    -   c. The syringe S is inserted into the valveless PIBA 210 (FIG.        20C).    -   d. The medication container and the syringe S combination are        rotated up-side-down. (FIG. 20D).    -   e. The medication container and syringe S combination are placed        into the filling station 5 via Yoke 82B or Self-Centering jaws        82C (FIG. 20E).    -   f. After filling, the medication container and syringe S        combination are removed from the filling station 5.    -   g. The medication container and syringe S combination are then        up-righted (FIG. 20C), and the filled syringe is then removed        from the medication container.

Filling a Syringe S Using a PIBA (with Valve) 212/225 (See FIGS. 5 and44)

The Self Sealing PIBA Insert 212 is pressed into the neck opening of amedication container and enables an oral syringe S to enter its centerhole and withdraw an amount of liquid from the medication containerwhile the medication container is positioned upside down. In addition,it also enables the syringe to be removed without leaking and themedication container to be shaken at the fill station 5 (FIG. 2 III),while it is positioned upside down and without leaking. The self sealingPIBA insert 212 also allows for syringes S to be removed after fillingwithout removing the medication bottle and repeat the filling ofsubsequent syringes S in cases where a quantity of syringes S are to befilled with the same medication. In the event of a scheduled shakingrequirement, after a specified amount of time, the system can shake themedication without removing it from the filling station (see FIG. 16A).Frequency and strokes per minute are pre-programmed into the system. Thesequence of operation is as follows:

-   -   a. Remove medicine bottle cap (FIG. 21A).    -   b. The self sealing PIBA insert 212 is inserted into the neck of        the container (FIG. 21B).    -   c. The medication container is turned upside down (FIG. 21C).    -   d. The neck of the container is placed into the Self Centering        Jaws 82C or Yoke 82B (FIG. 21D) Since the neck of the container        is held on center by the yoke 82B or Self Centering Jaws 82C,        the opening to the self sealing PIBA insert 212 will be properly        aligned with the syringe S and the mechanism for filling the        syringe.    -   e. The medication container platform 79 is lowered to securely        hold the medication container in place on the Self Centering        Jaws 82C (see FIG. 21D).    -   f. If the medication container needs to be shaken, it is shaken        at the programmed speed, duration and frequency (see FIG. 16A)        while still held in the filling station 5.    -   g. The syringe S is inserted into the self sealing PIBA insert        212 opening (FIG. 21E).    -   h. The syringe is filled.    -   i. The syringe is removed from the medication container.    -   j. If additional syringes need to be filled with the same        medication, the process is repeated while the medication bottle        remains held within the filler.    -   k. When all syringes S have been filled with the medication, the        medication container is removed.    -   l. This process continues until all syringes for that        prescription production run have been filled.

Filling an Oral Swine Using a Valved Self-Sealing Two Piece Cap withCommon Outer Diameter 220, 221 (See FIG. 5)

As described above, the cap comprises a common outer diameter portionand either an insertable or integrally-formed self-sealing insert whichenables an oral syringe S to enter its center hole while the Medicationcontainer is positioned upside down without leaking. The valvedself-sealing one or two-piece cap 220, 221 also allow syringes to beremoved after filling without removing the medication container from thefiling station 5 (see FIG. 2 III) and repeat the filling of subsequentsyringes S when a quantity of syringes are to be filled with the samemedication. In the event of a scheduled shaking requirement, after aspecified amount of time, the system can shake the medication withoutremoving it from the filling station (see FIG. 16A). Frequency andstrokes per minute are pre-programmed into the system. The sequence ofoperation is as follows:

-   -   a. Remove original cap (FIG. 19A).    -   b. Valved self-sealing one or two piece cap 220, 221 is        tightened onto the neck of the container (FIG. 19B).    -   c. Medication container is turned upside down (see FIG. 19C).        The neck of the container is placed into a slotted yoke 82B or        the self-centering spring loaded jaws 82C (FIG. 7B). Since the        neck of the container is held on center by the slotted yoke 82B,        or the self-centering spring loaded jaws 82C the opening to the        cap 220, 221 will be properly aligned with the syringe S and the        mechanism for filling the syringe S by pulling the syringe        plunger downward (see FIG. 19C).    -   d. The medication container platform 79 is lowered to securely        hold the medication container in place onto either the Yoke 82A        (see FIG. 19C).    -   e. If the medication container needs to be shaken, it is shaken        at the programmed speed, duration and frequency (see FIG. 16A).    -   f. The syringe S tip is inserted up, into the cap opening 220,        221.    -   g. The syringe S is filled by the syringe gripping arms 110, 111        and 112 which, in concert with arm 128, engage the syringe S        plunger, prime and pull the plunger to the exact fill dose (see        FIG. 19D).    -   h. The syringe is unclamped by the filler finger grippers 78 and        the syringe is removed from the Medication container (FIG. 19D).    -   i. If additional syringes S need to be filled with the same        medication, the process is repeated.    -   j. When all syringes have been filled with the medication, the        platform 79 rises and the medication bottle is removed.    -   k. This process continues until all syringes for that        prescription production run have been filled.

Filling a Syringe S Using a Push-in Tip 223 for Interfacing with LuerLock Oral Syringes (See FIGS. 27-28)

The push-in tip 223 is pressed into the nozzle opening of a Baxa™ orBaxa™-equivalent manufacturer-supplied medication container cap (FIG.27) or PIBA cap (FIG. 28). If a medication container with push-in tip223 requires shaking, this must be done either manually or with theoptional free standing shaker (FIG. 17). This must be repeated everytime shaking is required regardless of whether the same medication isbeing filled into multiple syringes. A protective cap 223C must beplaced over the Medication bottle during storage, to ensure cleanliness.The sequence of operation is as follows:

-   -   a. The push-in tip 223 is inserted into the nozzle opening of a        Baxa™ or Baxa™-equivalent manufacturer-supplied medication        container cap (FIG. 27) or PIBA cap (FIG. 28).    -   b. The syringe S is inserted into the push-in tip 223 (FIGS. 27C        and 28C).    -   c. The medication container and the syringe S combination are        rotated up-side-down.    -   d. The medication container and syringe S combination are placed        into the filling station 5 via Yoke 82A, Yoke 82B or        Self-Centering jaws 82C.    -   e. After filling, the medication container and syringe S        combination are removed from the filling station 5.    -   f. The medication container and syringe S combination are then        up-righted and the filled syringe is then removed from the        medication container.

Filling a Syringe S Using a Push-Pull Cap 224 for Use with a PIBA orBaxa™ or Baxa™-Equivalent Medication Container Cap and Luer Lock OralSyringe (FIGS. 29-32)

The push-pull cap 224 is inserted over the nozzle of a Baxa™ orBaxa™-equivalent manufacturer-supplied medication container cap (FIG.29) or into the nozzle of a PIBA (FIG. 31). Alternately, push-pull cap224 is made integral with either a Baxa™ or Baxa™-equivalentmanufacturer-supplied medication container cap (FIG. 30) or a PIBA (FIG.32) enabling the integral cap to be screwed directly onto or pusheddirectly into the neck opening of a medication container, respectively.All of these arrangements enable an oral syringe S to enter the centerhole of cap 224 and withdraw an amount of liquid from the medicationcontainer while the medication container is positioned upside down. Inaddition, they also enables the syringe to be removed without leakingand the medication container to be shaken at the fill station 5, whileit is positioned upside down and without leaking. The push-pull cap 224also allows for syringes S to be removed after filling without removingthe medication bottle and repeat the filling of subsequent syringes S incases where a quantity of syringes S are to be filled with the samemedication. In the event of a scheduled shaking requirement, after aspecified amount of time, the system can shake the medication withoutremoving it from the filling station (see FIG. 16A). Frequency andstrokes per minute are pre-programmed into the system. The sequence ofoperation is as follows:

-   -   a. For integral push-pull caps 224, remove medicine bottle cap;        for separable push-pull caps 224, insert push-pull cap 224        directly over or into a Baxa™ or Baxa™-equivalent        manufacturer-supplied medication container cap, respectively.    -   b. The medication container is turned upside down.    -   c. The neck of the container is placed into the filling station.    -   d. The medication container platform 79 is lowered to securely        hold the medication container in place at the filling station 5.    -   e. If the medication container needs to be shaken, it is shaken        at the programmed speed, duration and frequency (see FIG. 16A)        while still held in the filling station 5.    -   f. The syringe S is inserted into the nozzle 90 of push-pull cap        224.    -   g. The syringe is filled.    -   h. The syringe is removed from the medication container.    -   i. If additional syringes need to be filled with the same        medication, the process is repeated while the medication bottle        remains held within the filler.    -   j. When all syringes S have been filled with the medication, the        medication container is removed.    -   k. This process continues until all syringes for that        prescription production run have been filled.

In the future, for drug anti-counterfeiting purposes, medicationcontainers may include 2D barcodes applied to them by the manufacturerswith unique ID numbers and other data. Consequently, medicationcontainers may be supplied to the pharmacies with a pre-applied 2Dbarcode providing a unique ID number and other medication-related data.When this is the case, the system does not require that a specialbarcode label with information on the medication be generated andattached to the base of the medicine container. The medication ContainerLogin & Orientation Station 1 may be bypassed and/or omitted entirely,and the manufacturer's barcode on the container is utilized. A track,trace and control system is similar to the OSPS previously described isprovided. The objective of the simplified syringe filling and labelingsystem is to ensure that the proper medication is filled into thesyringe and that the syringe is labeled correctly. If an optional weightcheck or volume check station is utilized, the proper amount of fill canbe verified. The system minimizes downtime as well as processing time totake and fill orders, and is easy to clean and capable of maintaining anenvironment free from cross contamination. The system is open andaccessible and allows interaction and oversight by a human operator atmultiple points in the operation. Moreover, it is modular and permits adiffering and upgradeable level of operator participation (from asyringe filling device only to a semi-automated combination of labeling,filling, inspection, capping, and/or bagging functionality) based on theneed of the individual institution.

It should now be apparent that the above-described system is driven byprescription orders in a just-in-time environment, manages all thevarious prescription containers containing the pharmaceuticals to bedispensed, as well as variously-sized oral syringes, to automaticallyconverge them and orient, fill, label and cap each syringe and fullyverify its work as it proceeds in order to avoid medication errors inthe process. The pharmacy automation system for oral syringessubstantially improves the pharmacist and technician productivity andmaintains an environment free from cross contamination.

In all the above-described embodiments, the entire system is modular andpermits an upgradeable core based on the need of the individualinstitution. Optional system components such as the label photographingstation 98 resident at the Medication Container Orientation and Log-InStation may be purchase and added to the system subsequent to theoriginal purchase.

Having now fully set forth the preferred embodiment and certainmodifications of the concept underlying the present invention, variousother embodiments as well as certain variations and modifications of theembodiments herein shown and described will obviously occur to thoseskilled in the art upon becoming familiar with said underlying concept.It is to be understood, therefore, that the invention may be practicedotherwise than as specifically set forth in the appended claims and maybe used with a variety of materials and components. This application istherefore intended to cover any variations, uses, or adaptations of theinvention using its general principles. Further, this application isintended to cover such departures from the present disclosure as comewithin known or customary practice in the art to which this inventionpertains.

STATEMENT OF INDUSTRIAL APPLICABILITY

In hospitals around the world, many types of liquid medications arenecessarily administered orally to patients who cannot or are unwillingto receive the same medications by injection. Thus, for a typicalhospital, it may be necessary to fill hundreds or thousands of oralprescriptions each year by removing the prescribed amount of liquidmedication from a bulk liquid medication container and placing it intoan oral syringe in a clean environment. Filling an oral syringeprescription incorrectly, by placing the wrong medication, the wrongdosage, by mislabeling the syringe such that it is received by the wrongpatient, etc., can be harmful or even fatal to the patient who receivesthe medication (and to the patient who does not receive the propermedication). In addition, it is often necessary to rapidly fillprescriptions for oral syringes to promptly treat patients needing theliquid medication. A system for quickly and accurately filling severaloral syringes in a hospital setting would greatly increase patientsafety and treatment quality. The present invention is a system andmethods for the semi-automated filling, bagging, and labeling of severaloral syringe prescriptions, wherein each step in the filling, baggingand labeling procedure is performed at least in part by, and monitoredand tracked by, a device controlled by a programmable controller whichmay interface with a hospital prescription database to further eliminateerrors in filling oral syringes.

We claim:
 1. A system for semi-automated filling of syringes withmedicines from containers, said syringes being of various sizes andtypes all having a barrel, an annular flange encircling said barrel, aplunger slideably engaged in said barrel, and a flange at distal end ofsaid plunger, and said plurality of containers of medicines being ofvarious sizes and types, the system comprising: a programmablecontroller including software for controlling said system; a containerof medicine having an annular body and an aperture into said body foraccepting a syringe nozzle; a filling station, comprising: a syringeloading station for loading of a syringe, a container loading stationfor manual loading said container, said container loading stationincluding a gripper for gripping said container; and a plurality of armsfor manipulating said syringe when in said filling position, saidplurality of arms including at least a first arm and second arm bothterminating in a forked end for engaging the syringe, each arm beingindependently servo-controlled and articulating along an axis, saidfirst arm and said second arm being adapted to withdraw the plunger ofsaid syringe to fill said syringe with medicine; wherein said second armterminates in one or more right-angle plates each having a transversecurvilinear notch defining said forked-end terminus.
 2. The system forsemi-automated filling of syringes according to claim 1, furthercomprising: an extended bit located beneath said fixture for mountingone of said bulk medicine containers in an inverted filling position,said bit containing an annular cutout through its entire height, saidcutout being defined by an inner wall, said inner wall comprising anannular groove sized to hold a slide ring of a push-pull medicationcontainer cap; and an actuator operatively connected to said bit forcontrolling the vertical movement of said bit; wherein said operation ofsaid actuator controls the opening and closing of said push-pull valve.3. The system for semi-automated filling of syringes according to claim1, wherein said second arm extends vertically from a horizontal basemember of said filling station.
 4. The system for semi-automated fillingof syringes according to claim 3, wherein said second arm extendsthrough fluid-sealed bushings at an attachment point between saidhorizontal base member and said second arm.
 5. The system forsemi-automated filling of syringes according to claim 3, wherein: saidfirst arm comprises two right-angle plates each having a transversecurvilinear notch for gripping a top and a bottom of said annular flangeencircling said barrel of said syringe; and said second arm comprisesone right-angle plate having a transverse curvilinear notch for grippingsaid flange at said distal end of said plunger of said syringe.
 6. Thesystem for semi-automated filling of syringes according to claim 1,wherein said gripper for gripping said container is a pair ofself-centering jaws, said jaws comprising a pair of spring-loaded jawsslidably mounted on a ball-slide track for slidable separation.
 7. Thesystem for semi-automated filling of syringes according to claim 1,wherein said programmable controller is in communication with a hospitalcomputer system so that when an electronic prescription is entered intoin said hospital computer system for a dose of prescription medicine tobe administered via an syringe, data is transmitted from said electronicprescription to said system for automatically filling an syringe withsaid dose of prescription medicine.
 8. The system for semi-automatedfilling of syringes according to claim 1, wherein said filling stationcomprises a container holding yoke mounted to said filling station. 9.The system for semi-automated filling of syringes according to claim 8,wherein said container holding yoke is removably mounted.
 10. The systemfor semi-automated filling of syringes according to claim 8, furthercomprising a plurality of differently-sized container holding yokesselectably mounted to said filling station.
 11. The system forsemi-automated filling of syringes according to claim 8, furthercomprising a pusher platform opposed to said container holding yoke forbearing against a bottom side of a medicine container to hold itcaptive.
 12. The system for semi-automated filling of syringes accordingto claim 11, wherein said pusher platform has a window through it. 13.The system for semi-automated filling of syringes according to claim 12,further comprising a scanner at said filling station.
 14. The system forsemi-automated filling of syringes according to claim 13, wherein saidscanner is mounted at said filling station proximate said window forscanning a label on said medicine container through the window of saidpusher platform.
 15. The system for semi-automated filling of syringesaccording to claim 1, further comprising a shaker for shaking saidmedicine container.
 16. The system for semi-automated filling ofsyringes according to claim 15, wherein said shaker is integral to thegripper of said container loading station and is operatively connectedto said programmable controller for receiving instructions from saidcontroller regarding shake duration, intensity, and intervals.
 17. Thesystem for semi-automated filling of syringes according to claim 15,wherein said shaker is a stand-alone shaking station.
 18. The system forsemi-automated filling of syringes according to claim 15, wherein saidshaker is integral to said filling station.
 19. The system forsemi-automated filling of syringes according to claim 1, wherein saidcontainer of medicine is configured with a cap having a push-pull valve.20. A system for semi-automated filling of syringes with medicines fromcontainers, said syringes being of various sizes and types all having abarrel, an annular flange encircling said barrel, a plunger slideablyengaged in said barrel, and a flange at distal end of said plunger, andsaid plurality of containers of medicines being of various sizes andtypes, the system comprising: a container loading station for manualloading of said medication container; and a syringe loading station forloading of said syringe; wherein said syringe loading station comprisesa plurality of arms for manipulating said syringe when in said fillingposition, said plurality of arms including at least a first arm andsecond arm, said first arm comprising two right-angle plates each havinga transverse curvilinear notch for gripping a top and a bottom of saidannular flange encircling said barrel of said syringe, and said secondarm comprising one right-angle plate having a transverse curvilinearnotch for gripping said flange at said distal end of said plunger ofsaid syringe.
 21. A method for semi-automated filling of syringes withmedicines from containers, said syringes being of various sizes andtypes all having a barrel, an annular flange encircling said barrel, aplunger slideably engaged in said barrel, and a flange at distal end ofsaid plunger, and said plurality of containers of medicines being ofvarious sizes and types and bearing a manufacturer barcode label, themethod comprising the steps of: logging a plurality of bulk medicines incontainers by the substeps of, adapting a selected container of medicinefor insertion of a nozzle of a syringe; scanning the manufacturerbarcode label for medicine information, and automatically printing a newunique barcode label and attaching said barcode label to said medicinecontainer; compiling a plurality of syringe prescriptions to be filled;sorting said plurality of syringe prescriptions into batches, each batchcomprising a specified type of medicine; retrieving a medicine containercontaining said specified type of medicine; scanning the attached newunique barcode label to confirm that said retrieved medicine containercontains said specified type of medicine; guiding an operator toretrieve a syringe; automatically printing a label for the syringe andattaching said label to the syringe; scanning said printed syringelabel; loading said retrieved syringe and said retrieved medicinecontainer into said fill station; automatically filling the syringe frommedicine in said medication container by withdrawing a plunger of saidsyringe.
 22. The method for semi-automated filling of syringes accordingto claim 21, further comprising a step of inspecting the filled syringefor one of fill weight or volume.
 23. The method for semi-automatedfilling of syringes according to claim 21, further comprising a step ofautomatically labelling a package for packaging of said filled syringe.24. The method for semi-automated filling of syringes according to claim23, wherein said step of automatically labelling a package comprisesprinting an indicia on said package.
 25. The method for semi-automatedfilling of syringes according to claim 24, further comprising a step ofscanning the indicia for integrity.
 26. The method for semi-automatedfilling of syringes according to claim 23, further comprising a step ofplacing the filled syringe in the package and sealing the package. 27.The method for semi-automated filling of syringes according to claim 21,wherein said step of automatically filling the syringe comprisesautomatically shaking said container for a prescribed duration andintensity at prescribed intervals.
 28. The method for semi-automatedfilling of syringes according to claim 21, wherein said step ofautomatically filling the syringe with medicine in said medicationcontainer by withdrawing a plunger of said syringe comprisesautomatically withdrawing a plunger of said syringe with aservo-controlled arm for manipulating said plunger.
 29. The method forsemi-automated filling of syringes according to claim 28, wherein saidservo-controlled arm further comprises a plurality of servo-controlledarms further including at least a first arm and second arm bothterminating in a forked end for engaging the syringe, each arm beingindependently servo-controlled and articulating along at least one axis.30. The method of claim 21, wherein each step in the method furthercomprises scanning said unique barcode label on said medicationcontainer and said syringe label to confirm that the syringe andmedication container are handled according to said plurality of syringeprescriptions.
 31. The method for semi-automated filling of syringesaccording to claim 21, wherein said step of adapting a selectedcontainer of medicine for insertion of a nozzle of a syringe comprises astep of replacing the manufacturer-supplied cap with a push-pull cap.